MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-06 for * 0013-7296 manufactured by Phs Custom Packaging.
[17218276]
A hair was found inside a custom laparoscopic instrument pack that was ordered from a supplier.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4911604 |
| MDR Report Key | 4911604 |
| Date Received | 2015-07-06 |
| Date of Report | 2015-07-06 |
| Date of Event | 2015-06-25 |
| Report Date | 2015-07-06 |
| Date Reported to FDA | 2015-07-06 |
| Date Reported to Mfgr | 2015-07-14 |
| Date Added to Maude | 2015-07-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | TRAY, SURGICAL |
| Product Code | LRP |
| Date Received | 2015-07-06 |
| Model Number | * |
| Catalog Number | 0013-7296 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHS CUSTOM PACKAGING |
| Manufacturer Address | 42500 WINCHESTER ROAD TEMECULA CA 92590 US 92590 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-06 |