Print-ready dossier — use your browser's print dialog to save as PDF.
BUG
Model BUG SMALL 856 HIGH LOW WORKING CHAIR, LIGHT GREY PINK/BLUE · ORMESA SRL · DI 08055715703120
INM — Chair, With Casters · Class I · 21 CFR 890.3100
UDILibrary device dossier · generated 2026-09-11 · 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 (0)
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-04
0
1
2020-02
0
1
2021-05
0
1
2021-08
0
1.67
2021-09
0
1
2021-10
0
1
2021-11
0
2
2021-12
0
8
2022-02
0
2
2022-03
0
1
2022-08
0
1
2022-09
0
1
2022-10
0
1
2023-02
0
1
2023-07
0
1
2023-12
0
1
2024-01
0
1
2025-01
0
1
2025-03
0
2
2025-05
0
1
2025-08
0
1
2025-09
0
1
2026-02
0
1
2026-04
0
1.8
2026-05
0
7.25
2026-06
0
4.8
This device (reports/month)Average device in INM (reports/device/month)