MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-28 for CERAMO CONCEPT X PUNCH TEB-2X manufactured by Fehling Instruments Gmbh & Co. Kg.
[128874976]
In a (b)(6) hospital, a part of a manual rongeur (punch) has broken off. The broken part was retrieved from the patient. The patient was not harmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615005-2018-00002 |
| MDR Report Key | 8110919 |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-20 |
| Date of Event | 2018-11-07 |
| Date Mfgr Received | 2018-11-08 |
| Device Manufacturer Date | 2017-01-25 |
| Date Added to Maude | 2018-11-28 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS ULRIKE LINDNER |
| Manufacturer Street | HANAUER LANDSTR. 7A |
| Manufacturer City | KARLSTEIN, BAVARIA 63791 |
| Manufacturer Country | GM |
| Manufacturer Postal | 63791 |
| Manufacturer G1 | FEHLING INSTRUMENTS GMBH & CO. KG |
| Manufacturer Street | HANAUER LANDSTR. 7A |
| Manufacturer City | KARLSTEIN, BAVARIA 63791 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 63791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CERAMO CONCEPT X PUNCH |
| Generic Name | MANUAL RONGEUR |
| Product Code | HAE |
| Date Received | 2018-11-28 |
| Returned To Mfg | 2018-11-15 |
| Model Number | TEB-2X |
| Catalog Number | TEB-2X |
| Lot Number | X16L538CK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FEHLING INSTRUMENTS GMBH & CO. KG |
| Manufacturer Address | HANAUER LANDSTR. 7A KARLSTEIN, BAVARIA 63791 GM 63791 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-28 |