GENESIS KIT 13 COATED 5192701400 519270

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-22 for GENESIS KIT 13 COATED 5192701400 519270 manufactured by Coloplast A/s.

Event Text Entries

[176106961] The lot number was reviewed for complaint trend, nonconforming reports and capa review. 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


[176106962] According to the available information, the nature of the revision surgery was noted as size. The malleable device was removed due to risk of erosion, no erosion had occurred. It was noted that the patient wanted an inflatable device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2125050-2020-00071
MDR Report Key9618624
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-01-22
Date of Report2020-01-21
Date of Event2019-12-23
Date Mfgr Received2019-12-23
Date Added to Maude2020-01-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactSARAH O'GARA
Manufacturer Street1601 WEST RIVER ROAD NORTH
Manufacturer CityMINNEAPOLIS MN 55411
Manufacturer CountryUS
Manufacturer Postal55411
Manufacturer G1COLOPLAST MANUFACTURING US, LLC
Manufacturer Street1601 WEST RIVER ROAD NORTH
Manufacturer CityMINNEAPOLIS MN 55411
Manufacturer CountryUS
Manufacturer Postal Code55411
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGENESIS KIT 13 COATED
Generic NamePENILE PROSTHESIS
Product CodeFAE
Date Received2020-01-22
Model Number5192701400
Catalog Number519270
Lot Number6336739
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 2020-01-22

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