MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 60IN 2-0 S/A CTX LP; SUTURE, SURGICAL, ABSORBABLE

Model Number	D8588
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a c-section procedure on unknown date and the suture was used.It was reported that the suture rupture/breakage occurred there were no patient consequences reported.

• Brand Name: PDSII VIO 60IN 2-0 S/A CTX LP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9767855
• Report Number: 2210968-2020-01598
• Device Sequence Number: 3308170
• Product Code: NEW
• UDI-Device Identifier: 10705031030626
• UDI-Public: 10705031030626
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2020

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 Model Number: D8588
• Device Catalogue Number: D8588
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/28/2020
• Patient Sequence Number: 1