MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-24 for SHAVER WITH CHARGER DYND70800 manufactured by Medline Industries, Inc..
[118439543]
Employees smelled something burning and upon investigation, found the charge for the medline shaver emitting the odor and turning black / overheating, but no open flames noted. Charger unplugged and removed from service. This same event happened in the operating room on (b)(6) 2017 per biomed and is a fire hazard.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079416 |
| MDR Report Key | 7818866 |
| Date Received | 2018-08-24 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-08-13 |
| Date Added to Maude | 2018-08-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | SHAVER WITH CHARGER |
| Generic Name | RAZOR, SURGICAL |
| Product Code | LWK |
| Date Received | 2018-08-24 |
| Model Number | DYND70800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-24 |