MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for BOSTON SCIENTIFIC UPSYLON MESH manufactured by Boston Scientific Corporation.
[145541800]
In (b)(6) 2017 had pop surgery and sling. Began with pain, bleeding, uti until (b)(6) 2018 when i had surgery to remove mesh that eroded through bladder and vagina. Very difficult and painful surgery. Had stent in ureter and supra pubic catheter for a month. Now i'm so disgusted that since mesh was placed trans abdominally, i have no legal recourse immediately available to me. Mesh erosion - bladder/vagina. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086716 |
| MDR Report Key | 8623694 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-16 |
| Date of Event | 2018-12-11 |
| Date Added to Maude | 2019-05-20 |
| 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 | 3 |
| Brand Name | BOSTON SCIENTIFIC UPSYLON MESH |
| Generic Name | GYNECOLOGICAL LAPAROSCOPIC KIT - UPSYLON |
| Product Code | OHD |
| Date Received | 2019-05-17 |
| Device Availability | N |
| 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. Hospitalization; 2. Other; 3. Required No Informationntervention | 2019-05-17 |