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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 3-0 S/A PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE
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ETHICON INC. PDSII CLR 18IN 3-0 S/A PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE Back to Search Results
Catalog Number Z497G
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/03/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device me5297 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 a later date a supplemental medwatch will be sent.
 
Event or Problem Description
It was reported that the patient underwent an unknown plastic surgery on (b)(6) 2019 and suture was used.During the procedure, the suture was broken during use.There were no adverse consequences to the patient.
 
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Brand Name
PDSII CLR 18IN 3-0 S/A PS-2 PRM MP
Common Device Name
SUTURE, SURGICAL, ABSORBABLE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
MDR Report Key9130941
Report Number2210968-2019-88183
Device Sequence Number16722583
Product Code NEW
UDI-Device Identifier10705031061231
UDI-Public10705031061231
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) 09/03/2019
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 Date04/30/2023
Device Catalogue NumberZ497G
Device Lot NumberME5297
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/03/2019
Initial Report FDA Received Date09/27/2019
Patient Sequence Number1
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