PDI CASTILE SOAP TOWELETTE * D41900

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-15 for PDI CASTILE SOAP TOWELETTE * D41900 manufactured by Professional Disposables International, Inc..

Event Text Entries

[5059354] Patient was asked for a urine sample. Given specimen cup and wipe. As soon as patient cleaned herself she began to burn severely. Then labia and fingers stuck together. Patient and nurse pulled package from trash and discovered nurse had given her a skin barrier prep packet. Packaging very similar in size and color. Both are blue aqua and white.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4302695
MDR Report Key4302695
Date Received2014-10-15
Date of Report2014-10-15
Date of Event2014-10-09
Report Date2014-10-15
Date Reported to FDA2014-10-15
Date Reported to Mfgr2014-12-08
Date Added to Maude2014-12-08
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NamePDI CASTILE SOAP TOWELETTE
Generic NameSKIN, SOAP
Product CodeKOY
Date Received2014-10-15
Model Number*
Catalog NumberD41900
Lot Number11102527
ID Number*
Device AvailabilityY
Device Age1 DA
Device Sequence No1
Device Event Key0
ManufacturerPROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
Manufacturer Address100 PHILIPS PARKWAY MONTVALE, NJ 07645 US 07645

Device Sequence Number: 2

Brand NameALLKARE PROTECTIVE BARRIER WIPE
Generic NamePROTECTOR, OSTOMY
Product CodeEXE
Date Received2014-10-15
Model Number*
Catalog Number*
Lot Number11339A L3
ID Number*
Device AvailabilityY
Device Age1 DA
Device Sequence No2
Device Event Key0
ManufacturerCONVATEC INC
Manufacturer Address211 AMERICAN AVE GREENSBORO, NC 27409 US 27409


Patients

Patient NumberTreatmentOutcomeDate
10 2014-10-15

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