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3M™ Bair Hugger™
Model 55502 · 3M COMPANY · DI 00707387818906
DWJ — System, Thermal Regulating · Class II · 21 CFR 870.5900
UDILibrary device dossier · generated 2026-09-14 · 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)
2019-01
0
18.5
2019-02
0
16.4
2019-03
0
17.17
2019-04
0
19.4
2019-05
0
12
2019-06
0
17.67
2019-07
0
23
2019-08
0
27
2019-09
0
36.25
2019-10
0
41.75
2019-11
0
27.4
2019-12
0
38.75
2020-01
0
31
2020-02
0
49
2020-03
0
30.25
2020-04
0
13.78
2020-05
0
18.29
2020-06
0
18.13
2020-07
0
31.75
2020-08
0
31.6
2020-09
0
31.2
2020-10
0
12.29
2020-11
0
26.4
2020-12
0
20.6
2021-01
0
17.63
2021-02
0
22.71
2021-03
0
17.73
2021-04
0
11.85
2021-05
0
15.11
2021-06
0
15.82
2021-07
0
11.91
2021-08
0
14.2
2021-09
0
14.73
2021-10
0
13.33
2021-11
0
15.6
2021-12
0
19.92
2022-01
0
11.6
2022-02
0
15.25
2022-03
0
13.36
2022-04
0
19.3
2022-05
0
22.27
2022-06
0
20.17
2022-07
0
20.17
2022-08
0
18.73
2022-09
0
11.75
2022-10
0
14.5
2022-11
0
33.67
2022-12
0
17.64
2023-01
0
20.75
2023-02
0
18.8
2023-03
0
20.8
2023-04
0
9.22
2023-05
0
14.67
2023-06
0
14.15
2023-07
0
20.56
2023-08
0
12.31
2023-09
0
17.7
2023-10
0
11.17
2023-11
0
12.4
2023-12
0
14.21
2024-01
0
12.75
2024-02
0
15.38
2024-03
0
12.5
2024-04
0
10.59
2024-05
0
9.72
2024-06
0
8
2024-07
0
8.45
2024-08
0
12.33
2024-09
0
15.41
2024-10
0
10.29
2024-11
0
8.05
2024-12
0
7.73
2025-01
0
7.91
2025-02
0
7.94
2025-03
0
6.85
2025-04
0
7.11
2025-05
0
7.65
2025-06
0
9.29
2025-07
0
8.31
2025-08
0
7.33
2025-09
0
8.29
2025-10
0
9
2025-11
0
7.5
2025-12
0
7.67
2026-01
0
5.71
2026-02
0
9.62
2026-03
0
9.7
2026-04
0
6.67
2026-05
0
6.73
2026-06
0
7.5
This device (reports/month)Average device in DWJ (reports/device/month)