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 Number: 4302695
• MDR Report Key: 4302695
• Date Received: 2014-10-15
• Date of Report: 2014-10-15
• Date of Event: 2014-10-09
• Report Date: 2014-10-15
• Date Reported to FDA: 2014-10-15
• Date Reported to Mfgr: 2014-12-08
• Date Added to Maude: 2014-12-08
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: PDI CASTILE SOAP TOWELETTE
• Generic Name: SKIN, SOAP
• Product Code: KOY
• Date Received: 2014-10-15
• Model Number: *
• Catalog Number: D41900
• Lot Number: 11102527
• ID Number: *
• Device Availability: Y
• Device Age: 1 DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
• Manufacturer Address: 100 PHILIPS PARKWAY MONTVALE, NJ 07645 US 07645

Device Sequence Number: 2

• Brand Name: ALLKARE PROTECTIVE BARRIER WIPE
• Generic Name: PROTECTOR, OSTOMY
• Product Code: EXE
• Date Received: 2014-10-15
• Model Number: *
• Catalog Number: *
• Lot Number: 11339A L3
• ID Number: *
• Device Availability: Y
• Device Age: 1 DA
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: CONVATEC INC
• Manufacturer Address: 211 AMERICAN AVE GREENSBORO, NC 27409 US 27409

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-10-15