MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 36IN 1 S/A CTXB; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDPB371
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2019
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.
Event or Problem Description
It was reported a patient underwent an unknown surgery on (b)(4) 2019 and suture was used.The suture was detached from the needle during suturing.The lot number is unknown.Further details are not provided.No sample will be returned.There were no adverse consequences to the patient.

• Brand Name: PDS+ VIO 36IN 1 S/A CTXB
• 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: 8413679
• Report Number: 2210968-2019-79407
• Device Sequence Number: 239464
• Product Code: NEW
• UDI-Device Identifier: 10705031048874
• UDI-Public: 10705031048874
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/15/2019

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 Catalogue Number: PDPB371
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/12/2019
• Patient Sequence Number: 1