MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-03-30 for HOUSE-PAPARELLA CUR, DBL-ENDED AU13720 manufactured by Cardinal Health.
[700405]
Tip of currette broke of during a procedure. Broken piece had to be removed from the patient's ear. Additionally, the account stated tip of product broke off in patient's middle ear during an ear procedure while the physician was cutting bone. The broken piece had to be located and removed from the patient's ear with suction.
Patient Sequence No: 1, Text Type: D, B5
[8129911]
The product was received with about 4 to 5 mm of one end missing. Visual examination of surface shows no sign of oxidation or staining. Fracture started on inner surface and moved to outer surface with continued use. No absolute cause of the failure can be determined, but it is appears the product failed from forces being applied exceeding the strength of the material. Historical review showed no other failures of this type for instruments made during this time frame.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2007-00030 |
| MDR Report Key | 921236 |
| Report Source | 05 |
| Date Received | 2007-03-30 |
| Date of Report | 2007-03-29 |
| Date of Event | 2007-02-26 |
| Date Mfgr Received | 2007-03-04 |
| Date Added to Maude | 2007-10-02 |
| 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 | 2007-03-30 |
| Returned To Mfg | 2007-03-20 |
| Model Number | AU13720 |
| Catalog Number | AU13720 |
| Lot Number | A |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 893727 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-03-30 |