FDA Adverse Event
Injury
Summary report: N
UNKNOWN URETEX MESH PRODUCT
MDR report key: 3833421
·
Received May 19, 2014
Report
- Report Number
- 9615742-2014-00165
- Event Type
- Injury
- Date Received
- May 19, 2014
- Date of Event
- September 11, 2003
- Report Date
- May 7, 2014
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- OTN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE PATIENT ALLEGED INJURY. SHE STILL EXPERIENCES INFECTION, PAIN, URINARY PROBLEMS, INCONTINENCE, VAGINAL SCARRING, MESH EROSION, AND RECURRENCE OF PROLAPSE. CORRECTIVE SURGERY SCHEDULES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 296068 | UNKNOWN URETEX MESH PRODUCT | NONE | OTN | SOFRADIM PRODUCTION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Other |