MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-30 for ARMATEC * AR8033650 manufactured by Microtek Medical, Inc..
[4175692]
Prior to draping the microscope, the scrub tech found a large hair in the drape before unfolding it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3605188 |
| MDR Report Key | 3605188 |
| Date Received | 2014-01-30 |
| Date of Report | 2014-01-30 |
| Date of Event | 2014-01-24 |
| Report Date | 2014-01-30 |
| Date Reported to FDA | 2014-01-30 |
| Date Reported to Mfgr | 2014-02-04 |
| Date Added to Maude | 2014-02-04 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | ARMATEC |
| Generic Name | DRAPE, SURGICAL |
| Product Code | HMT |
| Date Received | 2014-01-30 |
| Model Number | * |
| Catalog Number | AR8033650 |
| Lot Number | D133092 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK MEDICAL, INC. |
| Manufacturer Address | 370 WABASHA STREET N. SAINT PAUL MN 55102 US 55102 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-30 |