FDA Adverse Event
Injury
Summary report: N
RESTORELLE Y SHAPE
MDR report key: 3842898
·
Received August 21, 2013
Report
- Report Number
- 2125050-2013-00162
- Event Type
- Injury
- Date Received
- August 21, 2013
- Date of Event
- September 26, 2011
- Report Date
- August 21, 2013
- Manufacturer
- COLOPLAST A/S
- Product Code
- OTO
- PMA / PMN Number
- K112322
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFO CONTAINED IN THIS REPORT.
Description of Event or Problem · 1
AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PT EXPERIENCED MESH EXPOSURE, PAIN, DYSPAREUNIA AND YEAST INFECTION. AN EXAMINATION UNDER GENERAL ANESTHESIA, EXCISION OF EXPOSED MESH AND REAPPROXIMATION OF THE VAGINAL MUCOSA, ROBOTIC EXPLORATION, DENSE ADHESIOLYSIS, EXCISION OF SACROCOLPOPEXY MESH, REAPPROXIMATION OF THE VAGINA, REMOVAL OF MESH FROM THE ANTERIOR AND POSTERIOR WALLS OF THE VAGINA WERE PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 407049 | RESTORELLE Y SHAPE | SURGICAL MESH | OTO | COLOPLAST A/S | 5014201400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |