MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-13 for ULTRA FAST-FIX 72201494 manufactured by Smith & Nephew Inc..
[5082053]
Doctor was performing surgical procedure which required use of curved needle delivery system. After the item was opened to sterile field, the surgeon tested it and the device would not work properly. He couldn't get the suture to express from end of needle. A new device was brought to the field and opened without problem. ======================manufacturer response for ultra fast-fix ab curved needle delivery system, split cannula, ultra fast-fix ab curved needle delivery system, split cannula (per site reporter). ======================arrange to return product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4289703 |
| MDR Report Key | 4289703 |
| Date Received | 2014-11-13 |
| Date of Report | 2014-11-13 |
| Date of Event | 2014-11-10 |
| Report Date | 2014-11-13 |
| Date Reported to FDA | 2014-11-13 |
| Date Reported to Mfgr | 2014-12-02 |
| Date Added to Maude | 2014-12-02 |
| 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 | ULTRA FAST-FIX |
| Generic Name | SUTURE, NONABSORBABLE, SYNTHETIC, POLYESTER |
| Product Code | GAS |
| Date Received | 2014-11-13 |
| Model Number | 72201494 |
| Catalog Number | 72201494 |
| Lot Number | 50509428 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW INC. |
| Manufacturer Address | 150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-13 |