FDA.reportPublic FDA data

MAUDE MDR 2163999

MDR report key
2163999
Report number
2125050-2011-00003
Event key
0
Event type
3
Date received
2011-07-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
TIM CRABTREE-RA MANAGER
Address
1601 W. RIVER ROAD N MINNEAPOLIS MN 55411 US
Phone
612-612-6123
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TOROSASALINE FILLED TESTICULAR PROSTHESISCOLOPLAST A/SFAF520650140052065014002506164Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-07-1501. R

Event Narratives#

D

Patient 1

TESTICULAR PLACED UNEVENTFULLY DURING PROCEDURE AND APPEARED TO BE IN GOOD CONDITION. ON SUBSEQUENT EXAMS THE PROSTHESIS WAS RIDING HIGH AND HARD & APPEARED TO HAVE DEFLATED. PATIENT REQUESTED REMOVAL. PHYSICIAN FEELS THE IMPLANT IS DEFECTIVE.

D

Patient 1

TESTICULAR PLACED UNEVENTFULLY DURING PROCEDURE AND APPEARED TO BE IN GOOD POSITION. ON SUBSEQUENT EXAMS THE PROSTHESIS WAS RIDING HIGH AND HARD & APPEARED TO HAVE DEFLATED. PATIENT REQUESTED REMOVAL OF THE IMPLANT. PHYSICIAN FEELS THE IMPLANT IS DEFECTIVE.

N

Patient 1

EVALUATION PENDING. A FOLLOW-UP REPORT WILL BE FILED.

N

Patient 1

ONE SALINE TESTICULAR DEVICE WAS RECEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED DEVICE REVEALED NO FUNCTIONAL ABNORMALITIES. LEAKAGE TESTING WAS PERFORMED. NO LEAKAGE WAS OBSERVED DURING THE TESTING OF THE DEVICE. MICROSCOPIC EXAMINATION REVEALED ONE PUNCTURE IN THE INJECTION PORT OF THE DEVICE. THERE WAS NO INDICATION THAT THE INJECTION PORT HAD BEEN PUNCTURED WITH A NEEDLE TO BE FILLED PRIOR TO IMPLANT AS THE DEVICE INSTRUCTIONS FOR USE (IFU) STATES.