MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-27 for TRANSVAGINAL MESH manufactured by Boston Scientific Corporation.
[103790907]
Reporter states that in 2012 she had a transvaginal mesh implanted. Since then she has been experiencing multiple infections in various areas including her esophagus, along with pain and suffering. She has undergone a total of 4 surgeries. First surgery was the placement of the mesh in 2012. Second was the explant of the mesh in (b)(6) 2015. Third was another surgery to correct bladder issues. The 4th was to treat a rectal prolapse which she believes was related to the transvaginal mesh.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076170 |
| MDR Report Key | 7376799 |
| Date Received | 2018-03-27 |
| Date of Report | 2018-03-27 |
| Date of Event | 2012-01-01 |
| Date Added to Maude | 2018-03-28 |
| 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 | PATIENT |
| 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 | TRANSVAGINAL MESH |
| Generic Name | GYNECOLOGICAL LAPAROSCOPIC KIT |
| Product Code | OHD |
| Date Received | 2018-03-27 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-27 |