ALIGN TO URETHRAL SUPPORT SYSTEM
Report
- Report Number
- 1018233-2013-02308
- Event Type
- Injury
- Date Received
- May 31, 2013
- Report Date
- October 24, 2018
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- FTL
- PMA / PMN Number
- K070073
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: "COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE ALIGN TO URETHRAL SUPPORT SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. TEMPORARY URINARY RETENTION, BLADDER OUTLET OBSTRUCTION, AND VOIDING DIFFICULTIES ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE MESH SLING IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER OR ANY VISCERA, WHICH MAY OCCUR DURING INTRODUCER NEEDLE PASSAGE. TRANSITORY IRRITATION AT THE OPERATIVE WOUND SITE, WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO INFLAMMATION, INFECTION, OR EROSION OF THE IMPLANT." (B)(4).
THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.
COMPLAINT NUMBER: (B)(4). THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED SLIPPED SLING (FOREIGN BODY IN PATIENT) SAWING INTO SCIATIC NERVE, PAIN, PELVIC AREA AND BUTTOCK PAIN, AMBULATORY DIFFICULTIES, BURNING SENSATION, URINARY TRACT INFECTION, URINARY RETENTION, DEPRESSION, ADDITIONAL SURGICAL AND NONSURGICAL INTERVENTIONS.
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BILATERAL LEG PAIN, INABILITY TO VOID, LEFT FOOT PAIN AND PARESTHESIA STATUS POST PELVIC FLOOR PROLAPSE REPAIR WITH MESH, EXCISION OF THE LEFT ARM OF THE MESH (PINNACLE), LEFT LOWER EXTREMITY PAIN, L5 PAIN SYNDROME AND S1 MOTOR DEFICIT, GROIN AND COCCYX PAIN, PELVIC PAIN, COCCYX TRIGGER POINT INJECTIONS, INABILITY TO STAND FOR LONG PERIODS, VAGINAL PAIN, PERINEAL PAIN, NEUROPATHY INVOLVING LOWER EXTREMITY AND GLUTEAL AREA, EXPLORATION OF THE RIGHT PARAVAGINAL SPACE WITH RELEASE OF FIBROTIC TISSUE, PERINEAL DRAINAGE, ABSCESS TO LABIA MINORA, NERVE INJURY ON LEFT SIDE OBTURATOR CANAL L5-S1, PERSISTENT RIGHT-SIDED PAIN, CLITORAL NUMBNESS, SCAR TISSUE, COCCYDYNIA, DEBILITATING RIGHT BUTTOCK PAIN, PELVIC FLOOR MUSCLE DYSFUNCTION, DIFFICULTY RETURNING TO WORK (SECONDARY TO PAIN), INTERNAL PELVIC FLOOR TREATMENTS, CLITORAL BURNING, BURNING WITH RADIATION DOWN RIGHT LEG, NERVE IMPINGEMENT FROM VAGINAL MESH, EXCISION OF VAGINAL MESH ON RIGHT SIDE (PINNACLE), POSTOPERATIVE ANEMIA, POSTOPERATIVE EXTRAPERITONEAL RIGHT DEEP PELVIC STRANDING, AIR AND SMALL HEMATOMAS, FEELING WEAK, EDEMA OVER THE RIGHT SACROSPINOUS LIGAMENT AND UROGENITAL ATROPHY.
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED DEVICE MALFUNCTION, LEG PAIN, AND UNSPECIFIED PELVIC TRAUMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240208 | ALIGN TO URETHRAL SUPPORT SYSTEM | FTL | C.R. BARD, INC. (COVINGTON) -1018233 | NA | HUUA0183 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | PINNACLE |