MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-12-26 for WALLACH FREEZER LL100 manufactured by Wallach Surgical Devices, Inc..
[20181]
When the defrost trigger was pressed while freezing a wart on the lower eyelid, the tip of the unit blew off and imbedded in the pt's eye. Pt had multiple surgeries on rt eye but lost vision due to the penetrating eye injury. Malpractice case ensued and the pt settled out of court.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1007999 |
| MDR Report Key | 29075 |
| Date Received | 1995-12-26 |
| Date of Report | 1995-12-14 |
| Date of Event | 1993-10-06 |
| Date Added to Maude | 1995-12-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WALLACH FREEZER |
| Generic Name | CRYOSURGICAL INSTRUMENT |
| Product Code | HQA |
| Date Received | 1995-12-26 |
| Model Number | LL100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 30075 |
| Manufacturer | WALLACH SURGICAL DEVICES, INC. |
| Manufacturer Address | 291 PEPE'S FARM RD MILFORD CT 06460 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 1995-12-26 |