D
Patient 1
IT WAS REPORTED THAT THE PT DEVELOPED AN ANTERIOR LATERAL SOLCUS MESH EXPOSURE APPROX 5 MONTHS AFTER PLACEMENT.
MAUDE MDR 3530644
- MDR report key
- 3530644
- Report number
- 1018233-2013-09680
- Event key
- 0
- Event type
- 3
- Date received
- 2013-12-11
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KIM SHIRAH
- Address
- 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
- Phone
- 770-770-7707
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ADJUST HELICAL SINGLE INCISION SLING | BARD SHANNON LIMITED | PAH | NA | BRD800SI | UNK | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-12-11 | 0 | 1. O |
Event Narratives#
N
Patient 1
THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNK; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. A MANUFACTURING REVIEW WAS CONDUCTED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS MANUFACTURING RELATED CAUSE FOR THIS EVENT. (B)(4).