MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-06-14 for HOUSE STAPES CURETTE, SLIGHT AU12450 manufactured by Cardinal Health.
[624065]
There was patient involvement, but no injury. The cup on both of them broke off during surgery in the same spot. They found one cup, but not the other one but do not believe it's in the patient. Additionally, account stated both items broke on a patient during the same mastoid ear procedure. The physician removed the broken piece from the patient with suction when the first one broke, but was not able to locate the broke piece on the second.
Patient Sequence No: 1, Text Type: D, B5
[7911339]
Both curettes were received for investigation with the cups broken off. Item #1- lot code "m" - fracture on surface shows evidence of an existing fracture; approximately 50% of surface shows dark colored oxidation; balance of surface has no oxidation. Indication of a previous crack in the rest of the shaft failed. Surface at fracture indicates a fairly brittle type of fracture indicative of a hardened material of this type. Item #2 - lot code "m" - surface of fracture indicates a fairly brittle type of fracture indicative of a hardened material. Remaining cup shows some indication of "hard" use - dents and damage to the sharpened edge. Device history record was reviewed and no trend was found or issue noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2007-00066 |
| MDR Report Key | 865310 |
| Report Source | 05 |
| Date Received | 2007-06-14 |
| Date of Report | 2007-06-13 |
| Date of Event | 2007-05-07 |
| Date Mfgr Received | 2007-05-23 |
| Device Manufacturer Date | 1984-01-01 |
| Date Added to Maude | 2007-07-18 |
| 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 | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD BLDG KB |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOUSE STAPES CURETTE, SLIGHT |
| Generic Name | CURETTE |
| Product Code | JYG |
| Date Received | 2007-06-14 |
| Returned To Mfg | 2007-06-05 |
| Model Number | AU12450 |
| Lot Number | M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 858920 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-14 |