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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 27IN 0 S/A CT-1 SUTURE, SURGICAL, ABSORBABLE

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ETHICON INC. PDS+ VIO 27IN 0 S/A CT-1 SUTURE, SURGICAL, ABSORBABLE Back to Search Results
Catalog Number PDP340H
Device Problem Break
Event Date 01/06/2019
Event Type  Malfunction  
Manufacturer Narrative

Product complaint # (b)(4). A manufacturing record evaluation was performed for the finished device mck785 number, and no non-conformance's were identified. To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent.

 
Event Description

It was reported that the patient underwent a tendon of achilles repair surgery in 2019 and the suture was used. During the suturing, the suture fractionated without making a relevant force and it broke. Another like suture was used to complete the procedure successfully. There were no patient consequences reported.

 
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Brand NamePDS+ VIO 27IN 0 S/A CT-1
Type of DeviceSUTURE, SURGICAL, ABSORBABLE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-JUAREZ
avenida de las torres 7125
col salvacar
ciudad juarez 32604
MX  32604
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville , NJ 08876-0151
9082182792
MDR Report Key8849206
Report Number2210968-2019-84973
Device Sequence Number1
Product CodeNEW
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPDP340H
Device LOT NumberMCK785
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/26/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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