MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for IMPLANT MESH UPSYLON Y SYN 831-820 manufactured by Boston Scientific Corporation.
[135743856]
Sudden onset of severe abdominal pain. Pain started at 1:15pm, went to the emergency room (er) around 3:00pm ct. Scan of abdominal pelvis demonstrates high suspicion for cecal volvulus, very weak and faint in triage. White count normal. Post op diagnosis: cecal volvulus caused by suture or mesh from bladder lift procedure. Strangulation of cecum and proximal right colon and terminal ileum. Gangrenous right colon cecum and terminal ileum, abdominal peritonitis, abdominal sepsis and infection from gangrenous cecum and right colon. This was by far the worst night of my life. I just turned 60 and i? M extremely fit and active with all aspects of my life.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083714 |
| MDR Report Key | 8310513 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-01 |
| Date of Event | 2018-12-31 |
| Date Added to Maude | 2019-02-06 |
| 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 | IMPLANT MESH UPSYLON Y SYN |
| Generic Name | GYNECOLOGICAL LAPAROACOPIC KIT |
| Product Code | OHD |
| Date Received | 2019-02-05 |
| Model Number | 831-820 |
| Lot Number | C002445 |
| Device Expiration Date | 2008-02-28 |
| 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. Life Threatening; 3. Other | 2019-02-05 |