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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG MINI-SIZE LID W/RETENTION PLATESILVER MINI CONTAINER BOTTOMS AND LIDS

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AESCULAP AG MINI-SIZE LID W/RETENTION PLATESILVER MINI CONTAINER BOTTOMS AND LIDS Back to Search Results
Model Number JK174
Device Problems Product Quality Problem (1506); Out-Of-Box Failure (2311)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Manufacturing site evaluation: evaluation on-going.
 
Event Description
Country of complaint: (b)(6). It is reported that the seals are faulty. Components in use listed as concomitant devices are: jk174 / mini-size lid w/retention platesilver. Jk188 / bottom f/mini container height: 57 mm.
 
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Brand NameMINI-SIZE LID W/RETENTION PLATESILVER
Type of DeviceMINI CONTAINER BOTTOMS AND LIDS
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
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
MDR Report Key7334583
MDR Text Key102339974
Report Number9610612-2018-00113
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K053389
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberJK174
Device Catalogue NumberJK174
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2016
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date03/12/2018
Event Location No Information
Date Manufacturer Received07/06/2016
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 Initial

Patient Treatment Data
Date Received: 03/13/2018 Patient Sequence Number: 1
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