MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-10 for CRO-DAVIS RETRACTOR * 8579 manufactured by Unk.
[18094377]
Used cro-davis retractor to retract oral cavity. Blade of the cro davis mouth gag size #4 "snapped" at the neck of the instrument while attempting to retract the cavity. No injury to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4209081 |
| MDR Report Key | 4209081 |
| Date Received | 2014-10-10 |
| Date of Report | 2014-10-10 |
| Date of Event | 2014-10-08 |
| Report Date | 2014-10-10 |
| Date Reported to FDA | 2014-10-10 |
| Date Reported to Mfgr | 2014-10-29 |
| Date Added to Maude | 2014-10-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRO-DAVIS RETRACTOR |
| Generic Name | RETRACTOR, ENT |
| Product Code | KAL |
| Date Received | 2014-10-10 |
| Model Number | * |
| Catalog Number | 8579 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-10 |