TOROSA 5206501400 5206502400

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-09-10 for TOROSA 5206501400 5206502400 manufactured by Coloplast A/s.

Event Text Entries

[21020576] Product not holding fluid-leak.
Patient Sequence No: 1, Text Type: D, B5


[21150794] Testicular devcie wasnot returned for evaluation. Therefore the complaint could not be verified.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2125050-2012-00077
MDR Report Key2738055
Report Source06
Date Received2012-09-10
Date of Report2012-09-10
Date of Event2012-08-06
Date Mfgr Received2012-08-13
Device Manufacturer Date2011-04-11
Date Added to Maude2012-09-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactTIM CRABTREE-RA MANAGER
Manufacturer Street1601 W. RIVER ROAD N
Manufacturer CityMINNEAPOLIS MN 55411
Manufacturer CountryUS
Manufacturer Postal55411
Manufacturer Phone6123024922
Manufacturer G1COLOPLAST MANUFACTURING US, LLC
Manufacturer Street1601 W. RIVER ROAD N
Manufacturer CityMINNEAPOLIS MN 55411
Manufacturer CountryUS
Manufacturer Postal Code55411
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTOROSA
Generic NameSALINE FILLED TESTICULAR PROSTHESIS
Product CodeFAF
Date Received2012-09-10
Model Number5206501400
Catalog Number5206502400
Lot Number2544038
Device Expiration Date2012-09-30
OperatorPHYSICIAN
Device AvailabilityY
Device Age2 YR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCOLOPLAST A/S
Manufacturer AddressHOLTEDAM-1 HUMLEBAEK, 3050 DA 3050


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-09-10

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