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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP INC ROUND FILTERS W/INDICATOR STERILE TECHNOLOGY

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AESCULAP INC ROUND FILTERS W/INDICATOR STERILE TECHNOLOGY Back to Search Results
Model Number US751
Device Problem Material Discolored (1170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2019
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 the filter during surgery. During preparation for a total joint procedure, the color indicator of the sterility filter caused concern. This occurred on one of the instrument containers. The malfunction did not cause harm to the patient. It contributed to a delay of 30-45 minutes in which the set was re-sterilized.
 
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Brand NameROUND FILTERS W/INDICATOR
Type of DeviceSTERILE TECHNOLOGY
Manufacturer (Section D)
AESCULAP INC
3773 corporate parkway
center valley PA 18034
Manufacturer (Section G)
AESCULAP INC
3773 corporate parkway
center valley PA 18034
Manufacturer Contact
lindsay chromiak
3773 corporate parkway
center valley, PA 18034
MDR Report Key8633967
MDR Text Key145916646
Report Number2916714-2019-00022
Device Sequence Number1
Product Code FRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUS751
Device Catalogue NumberUS751
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/08/2019
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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