MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-03-18 for HOUSE-PAPARELLA CUR, DBL-ENDED AU13720 manufactured by Cardinal Health.
[409645]
While doing surgery, the lip broke off in the patient's ear. The physician did retrieve the part. Additionally, account stated that the physician was using the house-paparella curettes to curette the patient's ear when the end broke off. He had to retrieve the broken piece with forceps. The physician lumed the curette around and continued to curette the patient's ear with the opposite end of the curette, but that end broke off as well. The physician retrieved the broken piece with forceps and completed the case with another curette without incident. The account further stated that the curette will be returned to cardinal for evaluation and the requested patient's information will be placed in the box with the curette.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2005-00041 |
| MDR Report Key | 582572 |
| Report Source | 05 |
| Date Received | 2005-03-18 |
| Date of Report | 2005-03-18 |
| Date Mfgr Received | 2005-02-17 |
| Date Added to Maude | 2005-03-21 |
| 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 | 3 |
| 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 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOUSE-PAPARELLA CUR, DBL-ENDED |
| Generic Name | CURETTE |
| Product Code | JYG |
| Date Received | 2005-03-18 |
| Model Number | AU13720 |
| Catalog Number | AU13720 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 572400 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * US |
| Baseline Brand Name | HOUSE-PAPARELLA CUR, DBL-ENDED |
| Baseline Generic Name | CURETTE |
| Baseline Model No | AU13720 |
| Baseline Catalog No | AU13720 |
| Baseline ID | NA |
| Baseline Device Family | INSTRUMENTS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-03-18 |