MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-12 for VAGINAL CERVICAL AHLUWALIA'S RETRACTOR ELEVATOR 60-6085-201 manufactured by Conmed Corp..
[2927725]
Conmed vcare vaginal cervical retractor elevator balloon noted to have a hole. Reason for use: laparoscopic hysterectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5027646 |
| MDR Report Key | 2834921 |
| Date Received | 2012-11-12 |
| Date of Report | 2012-11-12 |
| Date of Event | 2012-11-12 |
| Date Added to Maude | 2012-11-19 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAGINAL CERVICAL AHLUWALIA'S RETRACTOR ELEVATOR |
| Generic Name | VCARE MEDIUM |
| Product Code | HDP |
| Date Received | 2012-11-12 |
| Model Number | 60-6085-201 |
| Catalog Number | 60-6085-201 |
| Lot Number | 121001 1 |
| Device Expiration Date | 2014-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-11-12 |