MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for MICROTEK TRANSVAGINAL PROBE COVER PC0907NB manufactured by Microtek Medical Inc..
[138657134]
Probe cover broke during exam/use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8415850 |
| MDR Report Key | 8415850 |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-01 |
| Date of Event | 2018-09-27 |
| Report Date | 2019-03-01 |
| Date Reported to FDA | 2019-03-01 |
| Date Reported to Mfgr | 2019-03-13 |
| Date Added to Maude | 2019-03-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MICROTEK TRANSVAGINAL PROBE COVER |
| Generic Name | CABLE/LEAD/SENSOR/PROBE COVER, NON-STERILE |
| Product Code | KKX |
| Date Received | 2019-03-13 |
| Catalog Number | PC0907NB |
| Lot Number | 17262 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK MEDICAL INC. |
| Manufacturer Address | 13000 DEERFIELD PARKWAY, SUITE 300 ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-13 |