DEPEND FIT FLEX MALE S/M

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-08-06 for DEPEND FIT FLEX MALE S/M manufactured by Kimberly-clark Corporation Cold Springs.

Event Text Entries

[116059800] A manufacturer lot code was not provided. With no means to ascertain the manufacturer/asset line and day of production, no further investigation on documents and records can be performed. Complaints which are serious in nature are reviewed on a regular basis or for due cause to provide visibility and escalation. In addition, complaints are also monitored for trending on a monthly cadence. No further information is available at this time.
Patient Sequence No: 1, Text Type: N, H10


[116059801] Consumer's wife reported that in (b)(6) 2017 her husband experienced a bladder uti that required hospitalization for a week and a half. He was using either depend fit flex male or women product. Consumer's wife reported that the incontinence product was re-used on her husband. This report is for the fit flex male. Mdr 2184163-2018-00002 has been submitted for the fit flex max women product. He was prescribed antibiotics. His uti was resolved. Consumer's wife reported she was satisfied, no further follow ups are tasked.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2184163-2018-00003
MDR Report Key7751589
Report SourceOTHER
Date Received2018-08-06
Date of Report2018-08-06
Date of Event2017-09-01
Date Mfgr Received2018-06-14
Date Added to Maude2018-08-06
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 FDA3
Event Location3
Manufacturer ContactDR. MARIAN VARGAS
Manufacturer Street2100 WINCHESTER RD
Manufacturer CityNEENAH WI 54956
Manufacturer CountryUS
Manufacturer Postal54956
Manufacturer Phone9207215889
Manufacturer G1KIMBERLY-CLARK CORPORATION COLD SPRINGS
Manufacturer Street1050 COLD SPRING RD.
Manufacturer CityNEENAH WI 54956
Manufacturer CountryUS
Manufacturer Postal Code54956
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEPEND
Generic NameGARMENT, PROTECTIVE, FOR INCONTINENCE
Product CodeEYQ
Date Received2018-08-06
Model NumberFIT FLEX MALE S/M
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKIMBERLY-CLARK CORPORATION COLD SPRINGS
Manufacturer Address1050 COLD SPRING RD. NEENAH WI 54956 US 54956


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2018-08-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.