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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 18IN 4-0 S/A PS-5 PRM; SUTURE, SURGICAL, ABSORBABLE
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ETHICON INC. PDSII VIO 18IN 4-0 S/A PS-5 PRM; SUTURE, SURGICAL, ABSORBABLE Back to Search Results
Catalog Number D8252
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/15/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pck794 batch number, and no non-conformances 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 or Problem Description
It was reported that the patient underwent an unknown surgery on (b)(6) 2019 and the suture was used.The needle was broken during use.There were no patient consequences reported.No further information is available.
 
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Brand Name
PDSII VIO 18IN 4-0 S/A PS-5 PRM
Common Device Name
SUTURE, SURGICAL, ABSORBABLE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key9291690
Report Number2210968-2019-89678
Device Sequence Number13953817
Product Code NEW
UDI-Device Identifier10705031029644
UDI-Public10705031029644
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
N18331
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date02/29/2024
Device Catalogue NumberD8252
Device Lot NumberPCK794
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/14/2019
Initial Report FDA Received Date11/07/2019
Patient Sequence Number1
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