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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON LLC PROLENE SUTURE MESH, SURGICAL, POLYMERIC

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ETHICON LLC PROLENE SUTURE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 8706
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/07/2020
Event Type  malfunction  
Event Description
Multiple 6-0 prolene sutures with common lot number noted to be breaking along varying areas of the suture throughout the case. Fda safety report id #: (b)(4).
 
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Brand NamePROLENE SUTURE
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON LLC
somerville NJ
MDR Report Key10390350
MDR Text Key202614247
Report NumberMW5095991
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8706
Device Catalogue Number8706
Device Lot NumberPDH189
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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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