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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM STERILIZATION CONTAINERS

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AESCULAP AG BOTTOM FOR 3/4 CONTAINER HEIGHT:135MM STERILIZATION CONTAINERS Back to Search Results
Model Number JK742
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2020
Event Type  malfunction  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with product bottom for 3/4 container height: 135mm. According to the description: there is a needle-like stick on the handle. So a (b)(6) employee injured his hand temporarily. Additional information was not provided nor available. Additional patient information is not available. The adverse event is filed under aag reference (b)(4).
 
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Brand NameBOTTOM FOR 3/4 CONTAINER HEIGHT:135MM
Type of DeviceSTERILIZATION CONTAINERS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
nadine schweikart
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key10028879
MDR Text Key190899630
Report Number9610612-2020-00151
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K053389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/05/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK742
Device Catalogue NumberJK742
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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