MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-27 for ALLIGATOR FORCEPS 66735 manufactured by Centurion Medical Products Corporation.
[92924902]
Patient Sequence No: 1, Text Type: N, H10
[92924903]
Centurion sterile 5. 5" alligator forceps reorder # (b)(4) lot 2017061301 pulled from stock for use and noted to have debris versus black mold inside sterile unopened package and protective cover of clamp. Package remains unopened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7058601 |
| MDR Report Key | 7058601 |
| Date Received | 2017-11-27 |
| Date of Report | 2017-11-16 |
| Date of Event | 2017-11-09 |
| Report Date | 2017-11-16 |
| Date Reported to FDA | 2017-11-16 |
| Date Reported to Mfgr | 2017-11-16 |
| Date Added to Maude | 2017-11-27 |
| 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 | ALLIGATOR FORCEPS |
| Generic Name | FORCEPS, GENERAL & PLASTIC SURGERY |
| Product Code | GEN |
| Date Received | 2017-11-27 |
| Catalog Number | 66735 |
| Lot Number | 2017061301 |
| ID Number | (01)00653160025668(10)2017061 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS CORPORATION |
| Manufacturer Address | 100 CENTURION WAY WILLIAMSTON MI 48895 US 48895 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-27 |