FDA.reportPublic FDA data

MAUDE MDR 2465157

MDR report key
2465157
Report number
1018233-2011-00305
Event key
0
Event type
3
Date received
2011-10-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1AVAULTA SOLO SYNTHETIC SUPPORT SYSTEMBARD SHANNON LIMITED -3005636544OTPNA486100HUSC1568RR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-10-1401. R

Event Narratives#

D

Patient 1

IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PATIENT HAS EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, AND HAS SUSTAINED PERMANENT INJURY.

N

Patient 1

THE DEVICE REMAINS IMPLANTED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER FOUND NOTHING THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES EACH DEVICE STATES IN THE ADVERSE REACTIONS SECTION: "POTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING HEMATOMA, SEROMA, MUCOSAL OR VISCERAL EROSION, INFECTION, INFLAMMATION, SENSITIZATION, DYSPAREUNIA, SCARIFICATION, AND CONTRACTION, FISTULA FORMATION, EXTRUSION AND RECURRENCE OF VAGINAL WALL PROLAPSE. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, RECTUM, OR ANY VISCERA MAY OCCUR DURING NEEDLE PASSAGE." THE INSTRUCTIONS FOR USE STATES UNDER PRECAUTIONS: "THE MESH SHOULD ONLY BE USED BY PHYSICIANS WHO ARE TRAINED IN THE SURGICAL PROCEDURES AND TECHNIQUES REQUIRED FOR PELVIC FLOOR RECONSTRUCTION AND THEN IMPLANTATION OF NONABSORBABLE MESHES." (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 URINARY URGENCY, FREQUENCY, A RECURRENT VAGINAL BULGE, WORSENING PELVIC ORGAN PROLAPSE, AND COMPLETED URODYNAMIC STUDIES TO FIND SIGNIFICANT STRESS URINARY INCONTINENCE AND A SLIGHTLY LOW BLADDER CAPACITY. ASKS TO HAVE THE MESH REMOVED. SHE DID RETURN ((B)(6) 2011) TO HAVE A ROBOTIC SUPRACERVICAL HYSTERECTOMY, CERVICAL SACROPEXY, CONCOMITANT TVT EXACT RETROPUBIC SLING AND CYSTOSCOPY, VAGINAL WALL MESH EXCISED. IT IS UNCLEAR FROM THE OP REPORT IF BOTH ANTERIOR AND POSTERIOR MESH WAS EXCISED. AFTER THIS SURGERY, IT WAS RECOMMENDED SHE TRY URETHRAL BULKING AGENTS. THERE IS NO RECORD THAT THE PATIENT RETURNED FOR THIS PROCEDURE.

N

Patient 1

THIS REPORT IS FILED AS A CORRECTION TO THE IFU. ADVERSE REACTIONS: POTENTIAL ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING HEMATOMA, SEROMA, MUCOSAL OR VISCERAL EROSION, INFECTION, INFLAMMATION, SENSITIZATION, DYSPAREUNIA, SCARIFICATION AND CONTRACTION, FISTULA FORMATION, EXTRUSION AND RECURRENCE OF VAGINAL WALL PROLAPSE. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, RECTUM, OR ANY VISCERA MAY OCCUR DURING NEEDLE PASSAGE. 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.

N

Patient 1

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.