MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for CONNECT VCARE MEDIUM 60-6085-201A manufactured by Conmed Corporation.
[184178363]
While using the vcare, the pieces separated in the pt. Able to retrieve all the pieces without injury to the pt. The handle detached from the cup and the balloon parts. The cup and balloon were in the pt, but retrieved without a problem. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093808 |
| MDR Report Key | 9847876 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-09 |
| Date Added to Maude | 2020-03-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | CONNECT VCARE MEDIUM |
| Generic Name | CANNULA, MANIPULATION/INJECTOR, UTERINE |
| Product Code | LKF |
| Date Received | 2020-03-17 |
| Model Number | 60-6085-201A |
| Catalog Number | 60-6085-201A |
| Lot Number | 201912021 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-17 |