MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-19 for VERSAFLO HEADCOVER WITH INTEGRATED HEAD SUSPENSION S SERIES S-133L-5 manufactured by 3m Company.
[38539584]
Patient Sequence No: 1, Text Type: N, H10
[38539605]
New shipment of 3m versaflo hoods were opened and found to have holes in the seams. This would have led to employee/caregiver exposure if used in a clinical isolation setting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5446459 |
| MDR Report Key | 5446459 |
| Date Received | 2016-02-19 |
| Date of Report | 2016-02-17 |
| Date of Event | 2016-02-09 |
| Report Date | 2016-02-17 |
| Date Reported to FDA | 2016-02-17 |
| Date Reported to Mfgr | 2016-02-17 |
| Date Added to Maude | 2016-02-19 |
| 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 | 0 |
| 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 | VERSAFLO HEADCOVER WITH INTEGRATED HEAD SUSPENSION |
| Generic Name | RESPIRATOR, SURGICAL |
| Product Code | FXY |
| Date Received | 2016-02-19 |
| Model Number | S SERIES |
| Catalog Number | S-133L-5 |
| Lot Number | 00051131170711 |
| ID Number | 70-0715-3305-6 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY |
| Manufacturer Address | 3M CENTER 2510 CONWAY AVE BUILDING 275-5W-06 ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-19 |