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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG BOTTOM FOR 1/1 CONTAINER HEIGHT:120MM STERILE TECHNOLOGY

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AESCULAP AG BOTTOM FOR 1/1 CONTAINER HEIGHT:120MM STERILE TECHNOLOGY Back to Search Results
Model Number JK441
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: no product is at hand. An analysis is not possible. Conclusion and root cause: no product available and therefore an analysis is not possible but we assume based on the information available the root cause of the this failure is not product related. There is the possibility that the root cause of the problem is most probably usage related. Rational: according to the quality standard, a material defect or production error can be excluded. There is the possibility that the particles are abrasions and that the abrasions were caused by a screen basket. No capa is necessary.
 
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going. Device not returned.
 
Event Description
Country of complaint: usa. Opened aesculap tray and saw particles that look like aluminum.
 
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Brand NameBOTTOM FOR 1/1 CONTAINER HEIGHT:120MM
Type of DeviceSTERILE TECHNOLOGY
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key7249576
MDR Text Key296011301
Report Number9610612-2018-00059
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
PMA/PMN Number
K053389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK441
Device Catalogue NumberJK441
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Distributor Facility Aware Date01/05/2018
Event Location No Information
Date Manufacturer Received12/20/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/07/2018 Patient Sequence Number: 1
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