MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-16 for VAGINAL MESH manufactured by Johnson & Johnson / Ethicon, Inc..
[142461380]
Caller reported she had 5 surgeries related to her vaginal mesh. Since her initial implant, she has experienced incontinence causing embarrassment due to involuntary urination in public. Caller also expressed pain, cramping, emotional and mental health issues. Her marriage is suffering due to her inability to engage in intercourse and financial strain caused by the mesh. Caller was contacted by (b)(6) whom offered her (b)(6) dollars for damages as part of a settlement offer. However, they are requiring her to sign a contract awarding them 40% of money. Caller is unaware who (b)(6) is, and what his intentions are.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085949 |
| MDR Report Key | 8523259 |
| Date Received | 2019-04-16 |
| Date of Report | 2019-04-16 |
| Date Added to Maude | 2019-04-17 |
| 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 |
| 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 | VAGINAL MESH |
| Generic Name | MESH, SURGICAL, SYNTHETIC, UROGYCECOLOGIC |
| Product Code | PAG |
| Date Received | 2019-04-16 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON / ETHICON, INC. |
| Brand Name | VAGINAL MESH |
| Generic Name | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC |
| Product Code | PAG |
| Date Received | 2019-04-16 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON / [ETHICON, INC.] YD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-16 |