MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-12-12 for CONMED CORPORATION VCARE 60-6085-100 manufactured by Conmed Corp.
[2329936]
This pt went to her ob/gyn physician for her annual exam on (b)(6) 2011. She complained of not feeling well post hysterectomy. She had an mri for back pain prior to this appointment. Her ob/gyn reviewed the mri which showed something which could possibly be a foreign body. The pt was admitted for surgery on (b)(6) 2011. A retained portion of the uterine manipulator part was retrieved. The portion which was retrieved was the green cup distally to include the balloon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2396855 |
| MDR Report Key | 2396855 |
| Report Source | 99 |
| Date Received | 2011-12-12 |
| Date of Report | 2011-12-02 |
| Date of Event | 2011-01-18 |
| Date Facility Aware | 2011-10-04 |
| Report Date | 2011-12-02 |
| Date Reported to Mfgr | 2011-12-02 |
| Date Added to Maude | 2012-01-05 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONMED CORPORATION VCARE |
| Generic Name | VAGINAL CERVICAL RETRACTOR ELEVATOR |
| Product Code | HDL |
| Date Received | 2011-12-12 |
| Catalog Number | 60-6085-100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORP |
| Manufacturer Address | UTICA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-12-12 |