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

Catalog Number	PDP468H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).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.A manufacturing record evaluation was performed for the finished device mk6701 batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that a dog underwent a laparatomy for jejunal invagination on (b)(6) 2019 and suture was used.The suture was used continuously to approximate the muscle layers of the sterno-umbilical median incision.One day post op the suture had broken in one or more places.

• Brand Name: PDS+ VIO 27IN 1 S/A CP-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8946413
• Report Number: 2210968-2019-86423
• Device Sequence Number: 2099212
• Product Code: NEW
• UDI-Device Identifier: 10705031048379
• UDI-Public: 10705031048379
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• 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): 08/01/2019

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 Date: 08/31/2020
• Device Catalogue Number: PDP468H
• Device Lot Number: MK6701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/29/2019
• Patient Sequence Number: 1