MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-10-17 for PEDIATRIC OSTIUM PUNCH 8211-651 8211.651 manufactured by Richard Wolf Gmbh.
[19084252]
A rotatable ostium punch was in use in a pt's nasal cavity. During the anterior ethmoidectomy procedure, the movable jaw place broke off. The metal object was retrieved without difficulty. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-1997-00049 |
| MDR Report Key | 127749 |
| Report Source | 05 |
| Date Received | 1997-10-17 |
| Date of Report | 1997-09-18 |
| Date of Event | 1997-09-17 |
| Date Facility Aware | 1997-09-17 |
| Report Date | 1997-09-18 |
| Date Reported to Mfgr | 1997-09-18 |
| Date Mfgr Received | 1997-09-18 |
| Device Manufacturer Date | 1995-11-01 |
| Date Added to Maude | 1997-10-24 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEDIATRIC OSTIUM PUNCH |
| Generic Name | PEDIATRIC OSTIUM PUNCH |
| Product Code | KTF |
| Date Received | 1997-10-17 |
| Returned To Mfg | 1997-09-18 |
| Model Number | 8211-651 |
| Catalog Number | 8211.651 |
| Lot Number | A-L-U |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 124985 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STR. 32 KNITTLINGEN GM D 75438 |
| Baseline Brand Name | PEDIATRIC OSTIUM PUNCH |
| Baseline Generic Name | PEDIATRIC OSTIUM PUNCH |
| Baseline Model No | 8211-651 |
| Baseline Catalog No | 8211.651 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-10-17 |