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)
Date of Event	07/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 an animal underwent an ectopic urethra remediation procedure 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 broke.

• 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: 8945480
• Report Number: 2210968-2019-86422
• Device Sequence Number: 11377285
• 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