GOODNITES GIRL, L-XL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-29 for GOODNITES GIRL, L-XL manufactured by Kimberly-clark Corporation Paris Plant.

Event Text Entries

[125327743] The device history record (dhr) and quality records were reviewed. These documents demonstrate that procedures were correctly followed. 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


[125327744] This is a non-us event. This occurred in (b)(6). The consumer stated that her daughter developed a rash with two abscesses that needed to be drained and resulted in hospitalization. One abscess was drained, the second became infected and had to be surgically removed. Consumer reported that her child is improving and that the abscess is closing up. Two different packages of the product were used. The other package is reported under 1650783-2018-00001.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1650783-2018-00002
MDR Report Key8015201
Report SourceCONSUMER
Date Received2018-10-29
Date of Report2018-10-29
Date of Event2018-09-21
Date Mfgr Received2018-10-01
Device Manufacturer Date2018-08-06
Date Added to Maude2018-10-29
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 ROAD
Manufacturer CityNEENAH WI 54956
Manufacturer CountryUS
Manufacturer Postal54956
Manufacturer Phone9207215889
Manufacturer G1KIMBERLY-CLARK CORPORATION PARIS PLANT
Manufacturer Street2466 FARM ROAD 137
Manufacturer CityPARIS TX 75460
Manufacturer CountryUS
Manufacturer Postal Code75460
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGOODNITES
Generic NameGARMENT, PROTECTIVE, FOR INCONTINENCE
Product CodeEYQ
Date Received2018-10-29
Model NumberGIRL, L-XL
Lot NumberPA821813X1824
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKIMBERLY-CLARK CORPORATION PARIS PLANT
Manufacturer Address2466 FARM ROAD 137 PARIS TX 75460 US 75460


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2018-10-29

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