MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-10-21 for PROBE DRAPE W/GEL PC3787 manufactured by Microtek Dominicana, S.a..
| Report Number | 8043817-2019-40030 |
| MDR Report Key | 9216011 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-10-21 |
| Date of Report | 2019-10-21 |
| Date of Event | 2019-09-01 |
| Date Mfgr Received | 2019-10-15 |
| Date Added to Maude | 2019-10-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROBE DRAPE W/GEL |
| Generic Name | PROBE COVERS |
| Product Code | KKX |
| Date Received | 2019-10-21 |
| Model Number | PC3787 |
| Lot Number | D190499 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK DOMINICANA, S.A. |
| Manufacturer Address | LAS AMERICAS FREE ZONE PARK KM 22 SANTO DOMINGO, 11606 DR 11606 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-21 |