MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-23 for FRAZIER DURA HOOK BLUNT 5 26-1086 manufactured by Hebumedical Gmbh.
[46906805]
Importer informed manufacturer about event on 12/08/2015. Since neither the device nor device-specific information was provided, the manufacturing lot could not be determined. No investigation possible. Per complaint files of last three years, no similar issues have been recorded for this device.
Patient Sequence No: 1, Text Type: N, H10
[46906806]
As per importer report# (b)(4): doctor was excising/ undermining skin cancer for removal using the device to lift tissue when the tip broke off. No harm to patient. Extended procedure time by 5 minutes when searching for the tip, which was retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806609-2016-00003 |
| MDR Report Key | 5671915 |
| Date Received | 2016-05-23 |
| Date of Report | 2016-05-20 |
| Date of Event | 2013-07-08 |
| Date Mfgr Received | 2015-12-08 |
| Date Added to Maude | 2016-05-23 |
| 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 | 0 |
| Brand Name | FRAZIER DURA HOOK BLUNT 5 |
| Generic Name | HOOK |
| Product Code | GDG |
| Date Received | 2016-05-23 |
| Catalog Number | 26-1086 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-05-23 |