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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CASE MEDICAL INC. CASE MEDICAL WRAP, STERILIZATION

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CASE MEDICAL INC. CASE MEDICAL WRAP, STERILIZATION Back to Search Results
Model Number KSZ-39301BS
Device Problem Connection Problem (2900)
Patient Problem Insufficient Information (4580)
Event Date 10/07/2021
Event Type  malfunction  
Event Description
Cysto scopes filter container: the device that locks the filter in place does not click as they are supposed to.
 
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Brand NameCASE MEDICAL
Type of DeviceWRAP, STERILIZATION
Manufacturer (Section D)
CASE MEDICAL INC.
50 west st
bloomfield NJ 07003
MDR Report Key12845545
MDR Text Key281036555
Report Number12845545
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberKSZ-39301BS
Device Catalogue NumberKSZ-39301BS
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/28/2021
Event Location Hospital
Date Report to Manufacturer11/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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