MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-12-10 for ENT INSTRUMENT manufactured by Richard Wolf Medical Instruments.
[765983]
It was reported that a back biter ent instrument broke during a procedure and another procedure was done.
Patient Sequence No: 1, Text Type: D, B5
[8033793]
On 10/31/07, rwmic sales representative informed rwmic as indicated. There was insufficient information at this time. On 11/06/07, communication with enduser did not provide any information. User facility will not communicate directly. On 11/12/07, rwmic requested information from the enduser via letter, and as of current date, there has been no information provided. On 12/06/07, rwmic requested that enduser verify via email receipt of the letter. Should the device become available for evaluation, we will follow-up with any additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2007-00043 |
| MDR Report Key | 963151 |
| Report Source | 07 |
| Date Received | 2007-12-10 |
| Date of Report | 2007-12-10 |
| Date Mfgr Received | 2007-10-31 |
| Date Added to Maude | 2008-03-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELEANOR HALL |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENT INSTRUMENT |
| Generic Name | ENT INSTRUMENT |
| Product Code | KTF |
| Date Received | 2007-12-10 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 968763 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUMENTS |
| Manufacturer Address | VERNON HILLS IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-10 |