Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
13 linked reportsMalfunction 8Injury 5
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-02
0
1
2019-03
0
1
2019-04
0
1
2019-05
0
2
2019-07
0
2
2019-08
0
2
2019-09
0
3
2019-11
0
1
2019-12
0
2.5
2020-01
0
3
2020-02
0
3
2020-03
0
1.33
2020-04
0
2
2020-05
0
1
2020-06
0
2
2020-07
0
1.4
2020-08
0
2.67
2020-09
0
1
2020-10
0
1.75
2020-11
0
2
2020-12
0
1
2021-01
0
1
2021-02
0
1.83
2021-03
0
1.88
2021-04
0
1.43
2021-05
0
1.8
2021-06
0
2
2021-08
0
1.25
2021-09
0
1
2021-10
0
2.78
2021-11
0
1
2021-12
0
1.1
2022-01
0
1.22
2022-02
0
1.25
2022-03
0
4.57
2022-04
0
1
2022-05
0
2.67
2022-06
0
1.25
2022-07
0
2.6
2022-08
0
2.33
2022-09
0
1.47
2022-10
0
1.58
2022-11
0
1.4
2022-12
0
1.08
2023-01
0
1.27
2023-02
0
3.17
2023-03
0
2.58
2023-04
0
1.17
2023-05
0
1.22
2023-06
0
2.08
2023-07
0
1.6
2023-08
0
1.88
2023-09
0
6
2023-10
0
1.78
2023-11
0
1.8
2023-12
1
1.64
2024-01
0
1.79
2024-02
0
1.67
2024-03
0
1.64
2024-04
4
3
2024-05
0
1.89
2024-06
0
1.91
2024-07
0
2.73
2024-08
0
2.33
2024-09
4
2.15
2024-10
0
1.74
2024-11
0
1.41
2024-12
0
1.85
2025-01
0
3.39
2025-02
1
1.87
2025-03
1
1.65
2025-04
0
2.17
2025-05
0
1.78
2025-06
0
2.17
2025-07
1
1.88
2025-08
0
1.35
2025-09
0
2.5
2025-10
0
2.14
2025-11
0
1.93
2025-12
0
2.14
2026-01
0
2.6
2026-02
1
1.3
2026-03
0
3.45
2026-04
0
3
2026-05
0
2
2026-06
0
3.08
This device (reports/month)Average device in FQP, FSQ, FSY, FTD (reports/device/month)
Failure-mode summaryAI-generated
13 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2024-06-04
Z-2315-2024
Class II
Open, Classified
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light
system products listed below. Specific VidiaPort and Trulight product codes are also impacted as they are equipped with iLED 7 light-headsDistribution: Worldwide distribution.