MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-10 for WYNMAN CARB CROWN GRIPPER 72-10TC manufactured by G. Hipp & Son.
[60088129]
The device was manufactured and put into commercial distribution prior to 1998, 18+ years ago. It has been used long past its expected life, being subject to intensive reuse, as evidenced by its extremely worn condition, both overall and of the inserts in particular.
Patient Sequence No: 1, Text Type: N, H10
[60088130]
Facility reports that the insert broke while using. The doctor reports that he was gripping a crown when a tip of the carbide insert broke off in the mouth and was retrieved. No harm done.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010252-2016-00001 |
| MDR Report Key | 6092667 |
| Date Received | 2016-11-10 |
| Date of Report | 2016-11-10 |
| Date of Event | 2016-09-20 |
| Date Mfgr Received | 2016-10-11 |
| Date Added to Maude | 2016-11-10 |
| 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 |
| Reporter Occupation | MEDICAL ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GOTTFRIED HIPP |
| Manufacturer Street | CARL-BENZ-STRASSE 1 |
| Manufacturer City | NEUHAUSEN OB ECK, BADEN-WUERTTEMBERG 78579 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78579 |
| Manufacturer Phone | 4671463 |
| Manufacturer G1 | G. HIPP & SON |
| Manufacturer Street | CARL-BENZ-STRASSE 1 |
| Manufacturer City | NEUHAUSEN OB ECK, BADEN-WUERTTEMBERG 78579 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78579 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WYNMAN CARB CROWN GRIPPER |
| Generic Name | CROWN REMOVER |
| Product Code | EIS |
| Date Received | 2016-11-10 |
| Returned To Mfg | 2016-10-17 |
| Catalog Number | 72-10TC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | G. HIPP & SON |
| Manufacturer Address | CARL-BENZ-STRASSE 1 NEUHAUSEN OB ECK, BADEN-WUERTTEMBERG 78579 GM 78579 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-10 |