PELVICOL 2CM X 7CM 1.0MM
Report
- Report Number
- 9617613-2012-00137
- Event Type
- Injury
- Date Received
- August 21, 2012
- Report Date
- February 28, 2018
- Manufacturer
- COVIDIENT, FORMERLY TISSUE¿
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PROCEDURE: UROLOGICAL/GYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PT UNDERWENT A REPAIR PROCEDURE AND THE PT ALLEGEDLY EXPERIENCED PAIN AND INJURY. PT HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.
PER ADDITIONAL INFORMATION RECEIVED, COMPLICATIONS POST IMPLANT INCLUDE:ABDOMINAL PAIN, URINARY INCONTINENCE, CONSTIPATION, VAGINAL DISCHARGE, URINARY URGENCY, URGE INCONTINENCE, VAGINAL AND RECTAL PAIN, CONSTIPATION, URINARY TRACT INFECTIONS. (B)(6) 2007: UNDERWENT EXAMINATION UNDER ANESTHESIA WITH EXCISION OF SUTURE MATERIAL AND CYSTOSCOPY FOR ABDOMINAL AND SUPRAPUBIC PAIN STATUS POST SLING. MIXED STRESS/ URGE INCONTINENCE UNDER GENERAL LARYNGEAL MASK AIRWAY ANESTHESIA. CONDITIONS POST INTERVENTIONS SURGERY: DYSURIA, FREQUENCY, DYSPAREUNIA, INCONTINENCE, AND URGENCY, LOWER ABDOMINAL AND PELVIC PAIN, BURNING WITH URINATION. (B)(6) 2012: UNDERWENT CYSTOSCOPY AND BOTOX INJECTION, 200 UNITS OF BOTOX FOR REFRACTORY URGE INCONTINENCE. (B)(6) 2014: UNDERWENT CYSTOSCOPY WITH BOTOX INJECTION FOR URINARY INCONTINENCE .UNDER GENERAL ANESTHESIA. CONDITIONS POST THIRD INTERVENTION SURGERY: URGE URINARY INCONTINENCE, URINARY RETENTION, AND URINARY TRACT INFECTION, SUPRAPUBIC PAIN AND BLADDER SPASMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PELVICOL 2CM X 7CM 1.0MM | PELVICOL MESH | FTL | COVIDIENT, FORMERLY TISSUE¿ | 08B19-T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |