MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-08-23 for KERRISON RONGEUR, X-SMALL, SZ 0 AU6769 manufactured by Allegiance Healthcare Corp.
[290934]
During an eye case, the tip of the device broke off, as the physician was chipping at bone for the purpose of inserting tubes. The physician was not able to retrieve the foreign body. The pt is scheduled to have foreign body removed at later date by an ent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2002-00109 |
| MDR Report Key | 412566 |
| Report Source | 06 |
| Date Received | 2002-08-23 |
| Date of Report | 2002-08-20 |
| Date of Event | 2002-08-05 |
| Date Mfgr Received | 2002-08-06 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2002-08-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KERRISON RONGEUR, X-SMALL, SZ 0 |
| Generic Name | INSTRUMENT |
| Product Code | KBB |
| Date Received | 2002-08-23 |
| Model Number | AU6769 |
| Catalog Number | AU6769 |
| Lot Number | X02 |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 401621 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP |
| Manufacturer Address | 1500 WAUKEGAN RD MCGAW PARK IL 60085 US |
| Baseline Brand Name | KERRISON RONGEUR, X-SMALL, SZ 0 |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | AU6769 |
| Baseline Catalog No | AU6769 |
| Baseline ID | NA |
| Baseline Device Family | INSTRUMENT |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| 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; 2. Required No Informationntervention | 2002-08-23 |