D
Patient 1
THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.
MAUDE MDR 3466171
- MDR report key
- 3466171
- Report number
- 1018233-2013-09129
- Event key
- 0
- Event type
- 3
- Date received
- 2013-11-07
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 600
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- RENE HUCKABBY
- 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 | ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM | BARD SHANNON LIMITED | FTL | NA | BRD600HH | HUTH0088 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-11-07 | 0 | 1. R |
Event Narratives#
N
Patient 1
THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. (B)(4).
N
Patient 1
(B)(4).
D
Patient 1
PER ADD'L INFO RECEIVED, THE PT HAS EXPERIENCED UNSPECIFIED PAIN, UNSPECIFIED INFECTION, UNSPECIFIED URINARY PROBLEMS, UNSPECIFIED RECURRENCE, UNSPECIFIED BLEEDING, DYSPAREUNIA. VAGINAL SCARRING, UNSPECIFIED "OTHER" EMOTIONAL/PSYCHOLOGICAL INJURY, AND LOSS OF CONSORTIUM.