FDA.reportPublic FDA data

MAUDE MDR 9899358

MDR report key
9899358
Report number
2125050-2020-00290
Event key
0
Event type
3
Date of event
2020-03-03
Date received
2020-03-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STEPHANIE PERRYMAN
Address
1601 WEST RIVER ROAD NORTH MINNEAPOLIS, MN US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TITAN OTRINFLATABLE PENILE PROSTHESISCOLOPLAST A/SFHWESR8182400ESR8183224689R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-300

Event Narratives#

N

Patient 1

THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA REVIEW. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

D

Patient 1

ACCORDING TO THE AVAILABLE INFORMATION, THERE WAS A BREAK IN THE TUBING BY THE RIGHT CYLINDER. THE RESERVOIR WAS RETAINED AND THE PUMP WAS REPLACED.