TITAN TOUCH ES28221022 ES2822

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for TITAN TOUCH ES28221022 ES2822 manufactured by Coloplast A/s.

Event Text Entries

[187368484] The lot number was reviewed for complaint trend, nonconforming report and capa. 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.
Patient Sequence No: 1, Text Type: N, H10


[187368485] According to the available information, the device was removed due to an infection. There are no culture results available at this time. Nothing was implanted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2125050-2020-00283
MDR Report Key9903157
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-26
Date of Event2020-03-02
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSARAH O'GARA
Manufacturer Street1601 WEST RIVER ROAD NORTH
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Manufacturer G1COLOPLAST MANUFACTURING US, LLC
Manufacturer Street1601 WEST RIVER ROAD NORTH
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTITAN TOUCH
Generic NameINFLATABLE PENILE PROSTHESIS
Product CodeFHW
Date Received2020-03-31
Model NumberES28221022
Catalog NumberES2822
Lot Number6401893
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOLOPLAST A/S
Manufacturer AddressHOLTEDAM 1 HUMLEBAEK, 3050 DA 3050


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-31

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