MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-04-29 for ALLPORT MASTOID SEARCHER 6 1/2" AU5680 manufactured by Allegiance Healthcare.
[22186847]
The tip on the mastoid searcher broke off during a cervical spine procedure. The broken tip was not seen by the naked eye nor on x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-1998-00135 |
| MDR Report Key | 165176 |
| Report Source | 05,06 |
| Date Received | 1998-04-29 |
| Date of Report | 1998-04-29 |
| Date of Event | 1998-02-13 |
| Date Mfgr Received | 1998-04-01 |
| Date Added to Maude | 1998-05-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLPORT MASTOID SEARCHER 6 1/2" |
| Generic Name | INSTRUMENT |
| Product Code | JZC |
| Date Received | 1998-04-29 |
| Returned To Mfg | 1998-04-14 |
| Model Number | AU5680 |
| Catalog Number | AU5680 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 160761 |
| Manufacturer | ALLEGIANCE HEALTHCARE |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | ALLPORT MASTOID SEARCHER 61/2" |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | AU5680 |
| Baseline Catalog No | AU5680 |
| Baseline ID | NA |
| Baseline Device Family | INSTRUMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-04-29 |