MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-11 for VAGINAL-CERVICAL AHLUWALIA RETRACTOR manufactured by Conmed.
[5199592]
Vaginal-cervical ahluwalia retractor did not form a seal causing leakage of fluid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039636 |
| MDR Report Key | 4342790 |
| Date Received | 2014-12-11 |
| Date of Report | 2014-10-10 |
| Date of Event | 2014-09-26 |
| Date Added to Maude | 2014-12-19 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 RETRACTOR |
| Generic Name | RETRACTOR |
| Product Code | HDL |
| Date Received | 2014-12-11 |
| Lot Number | 1403041 |
| ID Number | REF # 60-6085-202 |
| Device Expiration Date | 2016-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-11 |