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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. CASTILE SOAP TOWELETTE; PROFESSIONAL USE SKIN CLEANSER TOWELETTE
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PROFESSIONAL DISPOSABLES INTERNATIONAL, INC. CASTILE SOAP TOWELETTE; PROFESSIONAL USE SKIN CLEANSER TOWELETTE Back to Search Results
Device Problems Product Quality Problem (1506); Use of Device Problem (1670)
Patient Problem Burning Sensation (2146)
Event Date 11/01/2021
Event Type  malfunction  
Event Description
The packaging for pdi nail polish remover pads and the pdi castile soap towelette are similar in packing, size, and design.There is a potential for the products to be switched when used on or by a patient.Suggestion made for the manufacturer to evaluate design for opportunities.Nurse was getting a clean catch urine, and pt was given nail polish remover wipes, (the wipes were alongside the urine cups) instead of the soap castile wipes.Mom assisted in wiping and pt began to cry, stating it was "burning".Writer noted that the wrong wipes were opened.Immediately used warm water wipes to remove the nail polish remover.Pt felt relief immediately.
 
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Brand Name
CASTILE SOAP TOWELETTE
Type of Device
PROFESSIONAL USE SKIN CLEANSER TOWELETTE
Manufacturer (Section D)
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
2 nice pak park
orangeburg NY 10962
MDR Report Key13059340
MDR Text Key282615822
Report Number13059340
Device Sequence Number1
Product Code KOY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/10/2021
Event Location Hospital
Date Report to Manufacturer12/22/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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