FURLOW INSERTER NON STERILE QB55551002

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 2018-03-22 for FURLOW INSERTER NON STERILE QB55551002 manufactured by Coloplast A/s.

Event Text Entries

[103161215] 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 of 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


[103161216] According to the available information, when using the keith needle on the dacron pull suture - when you deploy it through the glans the dacron suture is frayed and fall to bits. This means you cannot locate the implant in the shaft. There appears to be no clinical consequences. The operation time was excessive, but coloplast has not been alerted to any infection or impaired function.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610711-2018-00006
MDR Report Key7361404
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-03-22
Date of Report2018-07-10
Date Mfgr Received2018-03-01
Date Added to Maude2018-03-22
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 ContactSTEPHANIE PERRYMAN
Manufacturer Street1601 WEST RIVIER ROAD NORTH
Manufacturer CityMINNEAPOLIS MN 55411
Manufacturer CountryUS
Manufacturer Postal55411
Manufacturer Phone6124345685
Manufacturer G1COLOPLAST A/S MANUFACTURING FRANCE
Manufacturer Street9 AVENUE EDMOND ROSTAND
Manufacturer CitySARLAT-LA-CANEDA, 24206
Manufacturer CountryFR
Manufacturer Postal Code24206
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFURLOW INSERTER NON STERILE
Generic NameNEEDLE GUIDE
Product CodeKOA
Date Received2018-03-22
Returned To Mfg2018-03-06
Model NumberQB55551002
Catalog NumberQB55551002
Lot Number6009375
OperatorPHYSICIAN
Device AvailabilityR
Device AgeDA
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. Other 2018-03-22

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