MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-06-22 for TRIGEN 71634005 manufactured by Smith & Nephew, Inc..
[16839552]
It was reported that the nail cap could not be inserted during surgery and the surgeon had to use a second nail cap. Surgery time was extended by 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
[17054138]
Na
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2009-00595 |
| MDR Report Key | 1406164 |
| Report Source | 07 |
| Date Received | 2009-06-22 |
| Date of Report | 2009-06-18 |
| Date of Event | 2009-06-01 |
| Date Mfgr Received | 2009-06-17 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2009-06-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JERRY HOWARD |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013996153 |
| Manufacturer G1 | BROOKS MANUFACTURING SITE |
| Manufacturer Street | 1450 BROOKS RD. |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIGEN |
| Generic Name | NAIL CAP / LYT |
| Product Code | LYT |
| Date Received | 2009-06-22 |
| Catalog Number | 71634005 |
| Lot Number | 08DM14079 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | MEMPHIS TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-06-22 |