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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP, INC. JN STERILIZATION CONTAINER WRAP, STERILIZATION

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AESCULAP, INC. JN STERILIZATION CONTAINER WRAP, STERILIZATION Back to Search Results
Model Number NJ SERIES
Device Problems Contamination (1120); Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Aesculap jn series sterilization container form a build up of white powder on pans after several reuses. Several sites around country have had issues and aesculap has declared powder on inside of pan that contaminated surgical instruments safe to use. Fda safety report id # (b)(4).
 
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Brand NameJN STERILIZATION CONTAINER
Type of DeviceWRAP, STERILIZATION
Manufacturer (Section D)
AESCULAP, INC.
PA
MDR Report Key12266785
MDR Text Key264970764
Report NumberMW5102942
Device Sequence Number1
Product Code FRG
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNJ SERIES
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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