MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-14 for BOSTON SCIENTIFIC ADVANTAGE FIT 850-2110 manufactured by Boston Scientific.
[21011922]
I had tvt bladder sling surgery in (b)(6) 2010, and immediately noticed a pull in my groin. I had a catheter remain in my body with serious infections for nine weeks until a second surgery was performed (b)(6), 2010, to cut the mesh. It took several weeks of self cath and bladder spasms before i gained use of my bladder but i am still incontinent. Since the second surgery, leg and thigh pain increased over months and moved into my hip and buttocks. I now use a walking stick to walk. I had an emg which did not show anything, but i cannot afford more tests as i do not have insurance. I am in constant pain every day and this has stopped me working or being productive. I am a cripple from this product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019061 |
| MDR Report Key | 1969284 |
| Date Received | 2011-01-14 |
| Date of Report | 2011-01-14 |
| Date of Event | 2010-03-09 |
| Date Added to Maude | 2011-02-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON SCIENTIFIC |
| Generic Name | ADVANTAGE FIT TRANSVAGINAL TAPE |
| Product Code | MCA |
| Date Received | 2011-01-14 |
| Model Number | ADVANTAGE FIT |
| Catalog Number | 850-2110 |
| Lot Number | OML9092101 |
| Device Expiration Date | 2012-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2011-01-14 |