MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-11 for UPSYLON Y-MESH LOG226737 manufactured by Johnson & Johnson / Boston Scientific Corporation.
[136246442]
I had a prolapsed bladder and rectocele. The doctor implanted mesh to correct the bladder, however did nothing for the rectocele. I started having severe pain in my lower abdominal area after seven doctor? S, a surgeon said that the mesh had to come out. We set up the appointment for (b)(6) 2019, had it removed and will have to have still yet another surgery to correct the bladder and the rectocele in the near future, after healing from this surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083911 |
| MDR Report Key | 8331749 |
| Date Received | 2019-02-11 |
| Date of Report | 2019-02-08 |
| Date of Event | 2018-06-26 |
| Date Added to Maude | 2019-02-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| 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 | UPSYLON Y-MESH LOG226737 |
| Generic Name | GYNECOLOGICAL LAPAROSCOPIC KIT |
| Product Code | OHD |
| Date Received | 2019-02-11 |
| Catalog Number | 226737 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON / BOSTON SCIENTIFIC CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2019-02-11 |