MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-08 for DURAHOOK 1/4 HOOK 382800 manufactured by .
[28075474]
(b)(4). The device history reviews for the product durahook 1/4 hook 10 pkg/bx 6 hks/pkg, lot number 73d1500050 investigations did not show issues related to the complaint. The device sample has not been returned for investigation at the time of this report. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[28075475]
Alleged event: the item is discolored and breaks when stretched. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2015-00731 |
| MDR Report Key | 5138454 |
| Date Received | 2015-10-08 |
| Date of Report | 2015-09-10 |
| Date of Event | 2015-08-28 |
| Date Mfgr Received | 2015-09-10 |
| Device Manufacturer Date | 2015-04-08 |
| Date Added to Maude | 2015-10-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DURAHOOK 1/4 HOOK |
| Generic Name | INSTRUMENT,SURGICAL,NON-POWERED |
| Product Code | GDG |
| Date Received | 2015-10-08 |
| Catalog Number | 382800 |
| Lot Number | 73D1500050 |
| Device Expiration Date | 2016-10-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-08 |