MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-09 for NITRILE GLOVES GLV2303 manufactured by Owens & Minor.
[91459376]
Patient Sequence No: 1, Text Type: N, H10
[91459377]
Nurses found holes in gloves when they put them on.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7013452 |
| MDR Report Key | 7013452 |
| Date Received | 2017-11-09 |
| Date of Report | 2017-10-30 |
| Date of Event | 2017-09-18 |
| Report Date | 2017-10-30 |
| Date Reported to FDA | 2017-10-30 |
| Date Reported to Mfgr | 2017-10-30 |
| Date Added to Maude | 2017-11-09 |
| 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 |
| 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 | NITRILE GLOVES |
| Generic Name | GLOVES |
| Product Code | FMC |
| Date Received | 2017-11-09 |
| Catalog Number | GLV2303 |
| Lot Number | 1512GKN33AJ |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR |
| Manufacturer Address | 9120 LOCKWOOD BLVD MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-09 |