MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-19 for ARMATEC LEICA DRAPE AR 8033651 manufactured by Microtek Medical.
[824444]
Surgeon used drape and the lens broke, when the surgeon pulled back on the surgical instrument and it hit the lens.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005908 |
| MDR Report Key | 1015767 |
| Date Received | 2008-03-19 |
| Date Added to Maude | 2008-03-27 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARMATEC LEICA DRAPE |
| Generic Name | NONE |
| Product Code | HMT |
| Date Received | 2008-03-19 |
| Model Number | AR 8033651 |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 985448 |
| Manufacturer | MICROTEK MEDICAL |
| Manufacturer Address | COLUMBUS MS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-19 |