MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for PERMA-HAND manufactured by Ethicon, Inc.
[182980413]
A wrong number of needles than expected were in suture pack. When a package of ethicon control release 8 strands per pack perma- hand silk 3-0 (2. 0 metric) 18" (45 cm) sh 26 mm (1/2cm) taper needles packs was opened, there were 9 needles. 8 needles were in the slots, and 1 was lying on the right side of the white plastic edge. Lot number: pbd587.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9818676 |
| MDR Report Key | 9818676 |
| Date Received | 2020-03-11 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-08 |
| Report Date | 2020-02-11 |
| Date Reported to FDA | 2020-02-11 |
| Date Reported to Mfgr | 2020-03-11 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | PERMA-HAND |
| Generic Name | SUTURE, NONABSORBABLE, SILK |
| Product Code | GAP |
| Date Received | 2020-03-11 |
| Lot Number | PBD587 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC |
| Manufacturer Address | ROUTE 22 WEST, P.O. BOX 151 SOMERVILLE NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |