FDA.reportPublic FDA data

MAUDE MDR 2680902

MDR report key
2680902
Report number
1018233-2012-00857
Event key
0
Event type
3
Date received
2012-08-01
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
ANGELA ROBINSON
Address
8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALIGN? TO URETHRAL SUPPORT SYSTEM - HOOKBARD SHANNON LIMITEDOTNNAUNKNOWNUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-08-0101. R

Event Narratives#

D

Patient 1

THE PATIENT'S ATTORNEY HAS ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

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 RISK 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, 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 OVER-CORRECTION/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). 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.

D

Patient 1

PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED MESH EXCISION X2, URGENCY, DYSPAREUNIA, LEUKORRHEA, MIXED INCONTINENCE, RECURRENT VAGINAL PAIN AND DEPRESSION.

N

Patient 1

THE DEVICE THE REMAINS IMPLANTED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. (B)(4).

D

Patient 1

(B)(4). PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED MESH EROSION/EXPOSURE WHICH REQUIRED THE MESH TO BE TRIMMED.

N

Patient 1

(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.

D

Patient 1

PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAS EXPERIENCED BLOOD LOSS, EROSION, PAIN, URINARY LEAKAGE, PAINFUL INTERCOURSE, VAGINAL PAIN, DEPRESSION, MIXED URINARY INCONTINENCE, DYSPAREUNIA, FOREIGN BODY SENSATION, ATROPHIC VAGINITIS, NAUSEA, EXPOSED MESH, ANEMIA, LEFT VAGINAL DEFECT, DROP IN HEMATOCRIT/HEMOGLOBIN LEVEL, ANXIETY, DRAINAGE, FOREIGN BODY IN PATIENT, SUPRAPUBIC TENDERNESS, LOW URINE OUTPUT, LOW HEMOGLOBIN/HEMATOCRIT/RED BLOOD CELLS, ELEVATED WHITE BLOOD CELLS, ABDOMINAL DISTENTION, INDIGESTION, HEMATURIA, ABDOMINAL PAIN, SCARRING, DIZZINESS, LUMBAGO, BACK PAIN, SLEEP DISTURBANCE, VOMITING, RENAL CALCULI, HEMORRHOIDS, BURNING SENSATION, CRAMPING, DIARRHEA, FATIGUE, INFLAMMATION, DYSPNEA, URGENCY, ANXIETY, BLADDER (MUSCLE) SPASM, LEUKORRHEA, PELVIC PAIN, NON-SURGICAL AND ADDITIONAL SURGICAL INTERVENTIONS.