FDA.reportPublic FDA data

MAUDE MDR 3352405

MDR report key
3352405
Report number
1018233-2013-06537
Event key
0
Event type
3
Date received
2013-08-28
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
RENE HUCKABY
Address
8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
Phone
770-770-7708
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNK WOMEN'S HEALTH MESH PRODUCTFTL, OTOC.R. BARD, INC. (COVINGTON)FTLNAUNKUNKY N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-08-2801. R

Event Narratives#

D

Patient 1

(B)(4). IT WAS REPORTED BY THE PT'S ATTORNEY THAT AS A RESULT OF HAVING THE PRODUCT IMPLANTED, THE PT HAS EXPERIENCED EXCRUCIATING PAIN, LACERATION OF INTERNAL BODY TISSUE AND ORGANS, EROSION OF INTERNAL BODILY TISSUE, DYSPAREUNIA, DYSURIA, PAINFUL AND PERMANENT SCARRING, INABILITY TO WALK WITHOUT EXTREME PAIN, PERMANENT BODILY DISFIGUREMENT, PERMANENT BODILY IMPAIRMENT AND INJURIES, DAMAGE, RELATED SEQUELAE AND OTHER INJURIES REQUIRING ADDITIONAL SURGERIES AND CORRECTIVE TREATMENT.

N

Patient 1

THE PRODUCT FAMILY FOR THIS WOMEN'S HEALTHCARE PRODUCT IS UNK; THEREFORE, WE ARE UNABLE TO DETERMINE THE ASSOCIATED LABELING AND (B)(4) TO REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. "LAWYER-FILED REPORT - (B)(6)."