MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-23 for MEDIVATORS REF# 102875 manufactured by Medivators.
[83507779]
A live bat was in endopack upon opening, not used on pt. Sales rep notified, and picked up package that was contaminated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071742 |
| MDR Report Key | 6812655 |
| Date Received | 2017-08-23 |
| Date of Report | 2017-08-18 |
| Date of Event | 2017-08-18 |
| Date Added to Maude | 2017-08-23 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDIVATORS |
| Generic Name | ENDO CARRY-ON PROCEDURE KIT |
| Product Code | FRG |
| Date Received | 2017-08-23 |
| Returned To Mfg | 2017-08-18 |
| Model Number | REF# 102875 |
| Lot Number | 87/393/P/33 |
| Device Expiration Date | 2019-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 3150 POLLOK DR CONROE TX 77300 US 77300 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-23 |