MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-23 for 3M AURA HEALTH CARE PARTICULATE RESPIRATOR AND MASK TC-84A-5726 manufactured by 3m Company.
[109021415]
Patient Sequence No: 1, Text Type: N, H10
[109021416]
Nurse states that occasionally she will open a brand new n95 1870 mask for employee fit testing and notice that the top fold of the mask (which would go over the nose) is bunched up, as it will not straighten completely out, thus preventing a good protective seal fit. She notes that it is not on all of them just periodically comes across them. Concern that if staff use one of these that is bunched up during real patient care the seal will not be complete as they were fit tested, thus putting them at risk for exposure. Just a safety concern we would like to report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7536640 |
| MDR Report Key | 7536640 |
| Date Received | 2018-05-23 |
| Date of Report | 2018-05-17 |
| Date of Event | 2018-05-03 |
| Report Date | 2018-05-17 |
| Date Reported to FDA | 2018-05-17 |
| Date Reported to Mfgr | 2018-05-17 |
| Date Added to Maude | 2018-05-23 |
| 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 | 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 | 3 |
| Brand Name | 3M AURA HEALTH CARE PARTICULATE RESPIRATOR AND MASK |
| Generic Name | RESPIRATOR, SURGICAL |
| Product Code | MSH |
| Date Received | 2018-05-23 |
| Catalog Number | TC-84A-5726 |
| Lot Number | C173481 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Manufacturer Address | 3M CENTER, 2510 CONWAY AVENUE BLDG. 275-5W-06 SAINT PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-23 |