MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-03-30 for HOUSE-PAPERELLA CUR, DBL-ENDED AU13720 manufactured by Cardinal Health.
[18911309]
While doing surgery, the tip broke off in the pt's ear. The physician was able to retrieve broken part. Dr was using the house-paparella curelle to curelle the patient's ear when the end broke off. He retrieved the broken piece with forcepts. The pt did not require any medical or surgical intervention as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2005-00048 |
| MDR Report Key | 586717 |
| Report Source | 05 |
| Date Received | 2005-03-30 |
| Date of Report | 2005-03-30 |
| Date of Event | 2005-03-01 |
| Date Mfgr Received | 2005-03-01 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2005-04-01 |
| 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 | V-MUELLER |
| Manufacturer Street | * |
| Manufacturer City | MCGAW PARK |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOUSE-PAPERELLA CUR, DBL-ENDED |
| Generic Name | CURETTE |
| Product Code | JYG |
| Date Received | 2005-03-30 |
| Model Number | AU13720 |
| Catalog Number | AU13720 |
| Lot Number | A09 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 576565 |
| 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 | 2005-03-30 |