MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-03 for PDS 2-0 27" SH 26 MM 1/2C TAPER PDPB317H manufactured by Ethicon, Inc.
[3270116]
Closing layers where a colostomy had been when the needle broke off in the patient's tissue. Extensive palpation did not reveal needle piece. X-rays were done showing location of piece of needle. Piece of needle was retrieved. What was the original intended procedure? Colostomy take-down and hernia repair. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3080005 |
| MDR Report Key | 3080005 |
| Date Received | 2013-04-03 |
| Date of Report | 2013-04-03 |
| Date of Event | 2013-03-20 |
| Report Date | 2013-04-03 |
| Date Reported to FDA | 2013-04-03 |
| Date Reported to Mfgr | 2013-04-26 |
| Date Added to Maude | 2013-04-26 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | PDS |
| Generic Name | SUTURE, SURGICAL, ABSORBABLE |
| Product Code | GAS |
| Date Received | 2013-04-03 |
| Model Number | 2-0 27" SH 26 MM 1/2C TAPER |
| Catalog Number | PDPB317H |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC |
| Manufacturer Address | ROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 08876015 US 08876 0151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-03 |