MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2010-10-04 for HOUSE CURETTE ANGLED 020300 manufactured by Teleflex Medical.
[1834870]
The event is reported as: while using the curette, one tip broke off. No injuries reported.
Patient Sequence No: 1, Text Type: D, B5
[8918485]
Eval: method: dhr review performed. Results: dhr confirmed this was an isolated incident. Visual exam revealed the complaint was confirmed. The break appears to show the device was over stressed. The metal looks as though it was stressed and broke off. This product was made in 2004. Functional testing showed that a hardness test revealed the steel is in acceptable range. Conclusions: this is most likely a case of the product failing after its expected life and possibly was over stressed causing the product to fail at its weakest point. Mfg does not appear to be a root cause possibility. No corrective actions will be taken.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2010-00133 |
| MDR Report Key | 1880928 |
| Report Source | 06,07 |
| Date Received | 2010-10-04 |
| Date of Report | 2010-09-14 |
| Date of Event | 2010-08-19 |
| Date Mfgr Received | 2010-09-14 |
| Device Manufacturer Date | 2004-04-01 |
| Date Added to Maude | 2011-02-11 |
| 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 | MICHAEL TAGGART-VP |
| Manufacturer Street | P.O. BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334916 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 2917 WECK DRIVE |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOUSE CURETTE ANGLED |
| Generic Name | HOUSE CURETTE |
| Product Code | JYG |
| Date Received | 2010-10-04 |
| Returned To Mfg | 2010-09-16 |
| Model Number | NA |
| Catalog Number | 020300 |
| Lot Number | PP4 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-04 |