FDA.reportPublic FDA data

MAUDE MDR 3337506

MDR report key
3337506
Report number
1018233-2013-03463
Event key
0
Event type
3
Date received
2013-08-23
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 PRODUCTFTL, OTOC.R. BARD, INC. (COVINGTON)FTLNAUNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-08-2301. 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 SIGNIFICANT SEVERE AND PERMANENT PHYSICAL PAIN, SUFFERING, DISABILITY, PHYSICAL IMPAIRMENT, SUSTAINED PERMANENT INJURY, AND HAS UNDERGONE MEDICAL 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 DFMEA TO REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).