MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-07 for N95 RESPIRATOR MASK 1860 manufactured by 3m Company, 3m Health Care.
[27625705]
Patient Sequence No: 1, Text Type: N, H10
[27625706]
Several nurses were wearing the 3m n95 respirator mask when they had skin reactions to their faces. Symptoms were redness, swelling and rash.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5131043 |
| MDR Report Key | 5131043 |
| Date Received | 2015-10-07 |
| Date of Report | 2015-09-25 |
| Date of Event | 2015-09-23 |
| Report Date | 2015-09-25 |
| Date Reported to FDA | 2015-09-25 |
| Date Reported to Mfgr | 2015-09-25 |
| Date Added to Maude | 2015-10-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | N95 RESPIRATOR MASK |
| Generic Name | MASK, SURGICAL |
| Product Code | NZJ |
| Date Received | 2015-10-07 |
| Model Number | 1860 |
| Catalog Number | 1860 |
| Lot Number | VARIOUS (B15104, B15612 ETC |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY, 3M HEALTH CARE |
| Manufacturer Address | 3M CENTER, 2510 CONWAY AVE. BLDG. 275-5W-06 SAINT PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-10-07 |