MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2009-04-17 for ROTATABLE OSTIUM PUNCH 8211.661 manufactured by Richard Wolf Gmbh.
[1053506]
It was reported as a maude event report (foi) by the enduser to fda that a wolf sinus instrument back biting rongeur broke off in pt's right maxillary sinus cavity. The broken piece was retrieved.
Patient Sequence No: 1, Text Type: D, B5
[8144429]
Model # catalog # the 8211. 661 is the forceps attachment for the 8211. 651 rotatable punch. Enduser reported model # 8211. 661 and catalog # 8211. 611. Device evaluated by manufacturer: richard wolf has not seen the punch that was reported as broken and involved in an incident. At this time the enduser does not know the disposition of the punch. The punch was not received by richard wolf as a repair. At this time there is no info pertaining to any incident provided by the enduser to richard wolf. If such info is provided at a later date, a follow-up to fda will be done.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2009-00006 |
| MDR Report Key | 1368616 |
| Report Source | 00,06 |
| Date Received | 2009-04-17 |
| Date of Report | 2009-04-17 |
| Date of Event | 2009-02-19 |
| Date Facility Aware | 2009-03-23 |
| Report Date | 2009-04-17 |
| Date Reported to FDA | 2009-04-17 |
| Date Mfgr Received | 2009-03-23 |
| Date Added to Maude | 2010-05-05 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELEANOR HALL |
| Manufacturer Street | 353 CORPORATE WOODS PKWY. |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Manufacturer G1 | RICHARD WOLF GMBH |
| Manufacturer Street | PFORZHEIMER STR. 32 |
| Manufacturer City | KNITTLINGEN 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROTATABLE OSTIUM PUNCH |
| Generic Name | ROTATABLE OSTIUM PUNCH |
| Product Code | KTF |
| Date Received | 2009-04-17 |
| Model Number | 8211.661 |
| Catalog Number | 8211.661 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | KNITTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-17 |