MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-04 for MESH manufactured by Boston Scientific Corporation.
[119382607]
Bladder mesh, i have been trying to report my issues with the bladder mesh, but am having such horrible computer software email issues, my personal info has been compromised. Think someone is trying to claim as me.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079578 |
| MDR Report Key | 7846677 |
| Date Received | 2018-09-04 |
| Date of Report | 2018-08-29 |
| Date of Event | 2008-10-29 |
| Date Added to Maude | 2018-09-05 |
| 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 | 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 | MESH |
| Generic Name | GYNECOLOGICAL LAPAROSCOPIC KIT - UPSYLON Y MESH |
| Product Code | OHD |
| Date Received | 2018-09-04 |
| Device Expiration Date | 2018-10-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-09-04 |