MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-29 for HEMOSTATIC BIPOLAR INSTRUMENT 221265 manufactured by .
[18226833]
This occular cautery did not work. It was plugged in correctly and it did not function.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005212 |
| MDR Report Key | 991137 |
| Date Received | 2008-01-29 |
| Date of Report | 2008-01-29 |
| Date of Event | 2008-01-11 |
| Date Added to Maude | 2008-02-11 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOSTATIC BIPOLAR INSTRUMENT |
| Generic Name | WET FIELD ERASER |
| Product Code | HQP |
| Date Received | 2008-01-29 |
| Returned To Mfg | 2008-01-30 |
| Model Number | 221265 |
| Lot Number | 53615900 |
| Device Expiration Date | 2010-12-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 960823 |
| Manufacturer Address | 6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 32216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-29 |