MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-05-26 for FRAZIER DURA HOOK SHARP 5 26-1084 manufactured by Hebumedical Gmbh.
[45962016]
The device was returned without the broken-off tip. The device looked used, showing wear and scratches. Review of manufacturing records confirmed device conformance to specs at time of release. Since the device was manufactured in 2006 and showed evidence of extensive reuse, fracture due to excessive wear and tear seems to be the most probable cause.
Patient Sequence No: 1, Text Type: N, H10
[45962017]
Device was reported broken. (b)(6) 2015 customer reports that device broke during use when doctor was doing a procedure for skin cancer. No harm done. Piece easily retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806609-2016-00010 |
| MDR Report Key | 5681342 |
| Report Source | OTHER |
| Date Received | 2016-05-26 |
| Date of Report | 2016-05-25 |
| Date of Event | 2015-12-09 |
| Date Mfgr Received | 2015-12-17 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2016-05-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. THOMAS BUTSCH |
| Manufacturer Street | BADSTRASSE 8 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer Phone | 46194710 |
| Manufacturer G1 | HEBUMEDICAL GMBH |
| Manufacturer Street | BADSTRASSE 8 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FRAZIER DURA HOOK SHARP 5 |
| Generic Name | HOOK |
| Product Code | GDG |
| Date Received | 2016-05-26 |
| Catalog Number | 26-1084 |
| Lot Number | KE 4298 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEBUMEDICAL GMBH |
| Manufacturer Address | BADSTRASSE 8 TUTTLINGEN, 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-26 |