D
Patient 1
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.
MAUDE MDR 2764170
- MDR report key
- 2764170
- Report number
- 1018233-2012-01364
- Event key
- 0
- Event type
- 3
- Date received
- 2012-09-26
- 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
- LISA HALL
- 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 | AJUST ADJUSTABLE SINGLE INCISION SLING | BARD SHANNON LIMITED | FTL | NA | BRD700SI | HUUF0040 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-09-26 | 0 | 1. R |
Event Narratives#
N
Patient 1
THE DEVICE REMAINS IMPLANTED. 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 AJUST SLING SYSTEM MAY INCLUDE, BUT ARE NOT LIMITED TO: POSTOPERATIVE HEMATOMA, SEROMA, ABSCESS OR FISTULA FORMATION, OR SCARRING WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. URINARY RETENTION, BLADDER OUTLET OBSTRUCTION AND OTHER VOIDING DYSFUNCTIONS. THESE CONDITIONS MAY BE ASSOCIATED WITH OVERCORRECTION/TOO MUCH TENSION PLACED ON THE IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, URETHRA, OR ANY VISCERA, WHICH MAY OCCUR DURING THE IMPLANTATION PROCEDURE. IRRITATION AT THE OPERATIVE WOUND SITE WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO WOUND DEHISCENCE, INFLAMMATION AND/OR INFECTION. EXTRUSION THROUGH VAGINAL EPITHELIUM OR EROSION INTO SURROUNDING VISCERA AND/OR MUCOSA. INFLAMMATION, SENSITIZATION, PAIN, DYSPAREUNIA, SCARIFICATION, CONTRACTION, DEVICE MIGRATION AND FAILURE OF THE PROCEDURE RESULTING IN RECURRENCE OF INCONTINENCE." (B)(4).
N
Patient 1
(B)(4).
D
Patient 1
PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED LOWER ABDOMINAL PAIN, VAGINITIS, VAGINAL ATROPHY, ALLEGED RECURRENT URINARY TRACT INFECTIONS, CONTINUED SMOKING; CYSTOSCOPY, RIGHT URETEROSCOPY WITH LASER LITHOTRIPSY AND PLACEMENT OF 5 X 25 CM DOUBLE PIGTAIL STENT FOR RIGHT RENAL STONES; HORSESHOE KIDNEY, DYSPAREUNIA SECONDARY TO MESH EROSION, AND SURGICAL PROCEDURE INCLUDING REMOVAL OF PREVIOUSLY PLACED MIDURETHRAL SLING AND PLACEMENT OF A 2ND MESH MIDURETHRAL SLING FOR STRESS URINARY INCONTINENCE AND FAILED PREVIOUSLY PLACED MESH MIDURETHRAL SLING. FOLLOWING THE EXPLANT/REVISION AND IMPLANTATION OF THE SECOND MESH ON (B)(6) 2011, SHE SUFFERED FROM POSTOPERATIVE RETENTION OF URINE, SMALL AREA OF MESH EXPOSURE, REVISION OF MIDURETHRAL SLING MESH EXPOSURE FOR STRESS URINARY INCONTINENCE AND SMALL AREA OF MESH EXPOSURE; PELVIC PAIN, STRESS URINARY INCONTINENCE RESOLVED AFTER MIDURETHRAL SLING PLACEMENT; SMALL MESH EXPOSURE; DYSPAREUNIA, PELVIC FLOOR MUSCLE SPASM AND MYALGIA; NECK SPASM AND BACK MUSCLE SPASM; UNABLE TO DO PHYSICAL THERAPY DUE TO FAMILY SITUATION; STATES VAGINAL MESH IS STICKING OUT AND CUTTING HER AND BOYFRIEND AFFECTING RELATIONSHIP; RESECTION OF VAGINAL MESH/SLING AND CYSTOSCOPY FOR DIAGNOSES OF URINARY RETENTION, MESH EROSION AND STRESS URINARY INCONTINENCE; AND LAPAROSCOPIC BURCH PROCEDURE. FOLLOWING THE LAPAROSCOPIC BURCH PROCEDURE ON (B)(6) 2013, SHE SUFFERED FROM HOSPITALIZATION FROM (B)(6) 2013 THROUGH (B)(6) 2013 WITH DISCHARGE DIAGNOSES OF URINARY RETENTION, OBSTRUCTIVE UROPATHY, ACUTE KIDNEY INJURY, SEPTIC SHOCK, RESPIRATORY FAILURE, HORSESHOE KIDNEY, EXTENDED SPECTRUM BETA LACTAMASE POSITIVE ESCHERICHIA COLI BACTEREMIA. SURGICAL PROCEDURES DURING INPATIENT STAY INCLUDED EXAMINATION UNDER ANESTHESIA, CYSTOSCOPY, PLACEMENT OF FOLEY CATHETER AND RECONSTRUCTION OF THE URETHRA FOR DIAGNOSES OF URINARY RETENTION, ACUTE RENAL FAILURE AND URETHRAL TEAR; RETURN TO OR FOR EXPLORATORY LAPAROTOMY, EVACUATION OF FLUID AND PLACEMENT OF DRAIN INTO THE SPACE OF RETZIUS; AND PLACEMENT OF A TUNNELED CENTRAL VENOUS CATHETER IN THE RIGHT INTERNAL JUGULAR VEIN. FOLLOWING THIS HOSPITALIZATION, SHE REQUIRED HOME PHYSICAL THERAPY, OUTPATIENT IV ANTIBIOTIC THERAPY, AND SUFFERED FROM A URETHRAL FISTULA, REMOVAL OF IMPLANTED SUBCUTANEOUS VENOUS ACCESS CATHETER, URGENCY, ABDOMINAL BLOATING, DYSURIA, DIFFICULTY EMPTYING BLADDER, LEAKAGE WITH STRESS, LEAKAGE WITH URGE TO VOID, NOCTURIA, PROLAPSE SYMPTOMS, SUPRAPUBIC PAIN, AND URINARY RETENTION.