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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLLISTER INCORPORATED ADAPT LUBRICATING DEODORANT; OSTOMY CARE KIT

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HOLLISTER INCORPORATED ADAPT LUBRICATING DEODORANT; OSTOMY CARE KIT Back to Search Results
Patient Problem Insufficient Information (4580)
Event Date 01/01/2022
Event Type  Injury  
Event Description
Product and packaging has been tampered with.Ref reports: mw5152316, mw5152317, mw5152318, mw5152319, and mw5152320.
 
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Brand Name
ADAPT LUBRICATING DEODORANT
Type of Device
OSTOMY CARE KIT
Manufacturer (Section D)
HOLLISTER INCORPORATED
MDR Report Key18845053
MDR Text Key337088580
Report NumberMW5152321
Device Sequence Number1
Product Code PQE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/05/2024
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
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/05/2024
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
Patient EthnicityNon Hispanic
Patient RaceWhite
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