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Alexis ® O C-Section Protector - Retractor

Model G6313 · APPLIED MEDICAL RESOURCES CORPORATION · DI 00607915118129

KGW — Ring (Wound Protector), Drape Retention, Internal · Class II · 21 CFR 878.4370

KNA — Instrument, Manual, Specialized Obstetric-Gynecologic · Class II · 21 CFR 884.4530

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (9)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 8 · Injury: 1

358102019-01: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 2/device2019-12: 0 reports for this device; peer average 3/device2020-02: 2 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 3/device2022-02: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 10/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 1.75/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-03: 1 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 1.5/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 3.5/device2023-09: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 1.5/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 6/device2024-06: 0 reports for this device; peer average 1.67/device2024-07: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 3/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 2/device2025-01: 2 reports for this device; peer average 2/device2025-02: 2 reports for this device; peer average 2.8/device2025-04: 0 reports for this device; peer average 2.5/device2025-05: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 2.67/device2026-03: 2 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 2/device0106070810120203101203050910111202030405060809101112010203040506070809120203040607080910110102040507091011020304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0602
2019-0702
2019-0802
2019-1002
2019-1203
2020-0222
2020-0302
2020-1002
2020-1201
2021-0302
2021-0502
2021-0903
2021-1001
2021-1102
2021-1203
2022-0202
2022-0301
2022-0402
2022-0502
2022-06010
2022-0802
2022-0901
2022-1002
2022-1101.75
2022-1202
2023-0101
2023-0201
2023-0311
2023-0402
2023-0502
2023-0601.5
2023-0701
2023-0803.5
2023-0902
2023-1201.5
2024-0202
2024-0302
2024-0406
2024-0601.67
2024-0702
2024-0802
2024-0903
2024-1001
2024-1102
2025-0122
2025-0222.8
2025-0402.5
2025-0501
2025-0702
2025-0902
2025-1001
2025-1102
2026-0202.67
2026-0322
2026-0402
This device (reports/month)Average device in KGW, KNA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — APPLIED MEDICAL RESOURCES CORPORATION

  • Warning Letter 2015-04-10 Applied Medical Resources Corp
  • Warning Letter 2015-04-10 Applied Medical Resources Corp
  • NAI 2021-09-02 Applied Medical Resources Corp · 0 citations
  • NAI 2021-09-02 Applied Medical Resources Corp · 0 citations
  • NAI 2018-11-20 Applied Medical Resources Corp · 0 citations
  • NAI 2018-11-20 Applied Medical Resources Corp · 0 citations
  • VAI 2017-03-31 Applied Medical Resources Corp · 0 citations
  • VAI 2017-03-31 Applied Medical Resources Corp · 0 citations
  • NAI 2015-12-03 Applied Medical Resources Corporation · 0 citations
  • OAI 2015-10-14 Applied Medical Resources Corp · 8 citations
  • OAI 2015-10-14 Applied Medical Resources Corp · 8 citations
  • OAI 2014-12-16 Applied Medical Resources Corp · 8 citations
  • NAI 2014-12-16 Applied Medical Distribution Center · 0 citations
  • OAI 2014-12-16 Applied Medical Resources Corp · 8 citations