FDA.reportPublic FDA data

MAUDE MDR 2149428

MDR report key
2149428
Report number
1018233-2011-00161
Event key
0
Event type
3
Date received
2011-06-28
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
CHATERYL WASHINGTON
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 ANTERIOR SYNTHETIC SUPPORT SYSTEMC.R. BARD, INC.FTLNA486100HUTD1822R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-06-2801. R

Event Narratives#

D

Patient 1

IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE MESH IMPLANTED, THE PT EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY AND PERMANENT AND SUBSTANTIAL DEFORMITY, AND HAS UNDERGONE OR WILL UNDERGO CORRECTIVE SURGERY OR SURGERIES.

N

Patient 1

THE DEVICE REMAINS IMPLANTED. THE DEVICE HISTORY RECORD WAS REVIEWED FINDING NOTHING THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES EACH DEVICE STATES IN THE SECTION LABELED ADVERSE REACTIONS THAT 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 PRODUCT IS RECOMMENDED TO ONLY BE USED BY PHYSICIANS WHO ARE TRAINED IN THE SURGICAL PROCEDURES AND TECHNIQUES REQUIRED FOR PELVIC FLOOR RECONSTRUCTION AND THE IMPLANTATION OF NONABSORBABLE MESHES. (B)(4).