FDA Adverse Event
Injury
Summary report: N
UNKNOWN SOFRADIM PRODUCT
MDR report key: 3131350
·
Received May 20, 2013
Report
- Report Number
- 9615742-2013-00453
- Event Type
- Injury
- Date Received
- May 20, 2013
- Date of Event
- May 7, 2009
- Report Date
- April 24, 2013
- Manufacturer
- SOFRADIM PRODUCTION
- Product Code
- FTL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: IT WAS REPORTED IN THE PT'S MEDICAL RECORDS THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED VAGINAL BLEEDING, PELVIC PAIN, EXPOSURE VAGINAL SUTURES THAT REQUIRED REMOVAL PROCEDURES OF EXPOSED SUTURE; EROSION OF VAGINAL MUCOSA; DYSURIA; VAGINAL POLYPECTOMY; URINARY INCONTINENCE AND THE NEED FOR A SLING PROCEDURE SURGERY. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223364 | UNKNOWN SOFRADIM PRODUCT | SOFRADIM MESH | FTL | SOFRADIM PRODUCTION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other | ACELLULAR COLLAGEN MATRIX| PELVICOL ACELLULAR COLLAGEN MATRIX PELVICOL |