MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-01 for MERSILENE SURGICAL LIGATURE RS23/P30 manufactured by Ethicon, Inc..
[61552873]
Patient having cerclage, needle broke off of suture into vaginal wall. Surgeons were unable to retrieve it despite ultrasonography assistance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066517 |
| MDR Report Key | 6145073 |
| Date Received | 2016-12-01 |
| Date of Report | 2016-12-01 |
| Date of Event | 2016-11-23 |
| Date Added to Maude | 2016-12-05 |
| 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 | 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 | 0 |
| Brand Name | MERSILENE SURGICAL LIGATURE |
| Generic Name | MERSILENE SURGICAL LIGATURE |
| Product Code | HDH |
| Date Received | 2016-12-01 |
| Model Number | RS23/P30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-01 |