MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-08 for SURGICAL CLIPPER SINGLE BLADE FIXED HEAD NEXGEN 9681 USEN-ADDX5 manufactured by 3m Company, 3m Health Care.
[67236894]
Patient Sequence No: 1, Text Type: N, H10
[67236895]
The 3m clipper handle gets hot and the battery does not hold a charge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6310494 |
| MDR Report Key | 6310494 |
| Date Received | 2017-02-08 |
| Date of Report | 2016-10-12 |
| Date of Event | 2016-08-30 |
| Report Date | 2016-10-12 |
| Date Reported to FDA | 2016-10-12 |
| Date Reported to Mfgr | 2016-10-12 |
| Date Added to Maude | 2017-02-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SURGICAL CLIPPER SINGLE BLADE FIXED HEAD NEXGEN |
| Generic Name | RAZOR, SURGICAL |
| Product Code | LWK |
| Date Received | 2017-02-08 |
| Returned To Mfg | 2016-09-01 |
| Model Number | 9681 |
| Catalog Number | USEN-ADDX5 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY, 3M HEALTH CARE |
| Manufacturer Address | 3M CENTER, 2510 CONWAY AVENUE BLDG. 275-5W-06 SAINT PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-08 |