MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-02 for DERMAHOOK 382805 manufactured by Teleflex Medical Inc..
[53793659]
Patient Sequence No: 1, Text Type: N, H10
[53793660]
The surgery performed right craniotomy for dural arteriovenous fistula during the surgical procedure the hook broke while providing traction to tissue next to the brain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5924171 |
| MDR Report Key | 5924171 |
| Date Received | 2016-09-02 |
| Date of Report | 2016-08-24 |
| Date of Event | 2016-08-05 |
| Report Date | 2016-08-24 |
| Date Reported to FDA | 2016-08-24 |
| Date Reported to Mfgr | 2016-08-24 |
| Date Added to Maude | 2016-09-02 |
| 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 |
| 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 | DERMAHOOK |
| Generic Name | HOOK, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GDG |
| Date Received | 2016-09-02 |
| Model Number | 382805 |
| Catalog Number | 382805 |
| Lot Number | 73D1600149 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL INC. |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD MORRISVILLE, NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-02 |