MAUDE Adverse Event Report: ETHICON INC. PDS SUTURE 18"(45CM) 4-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D8252
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that the patient underwent mammectomy procedure on (b)(6) 2018 and suture was used.The suture was broken at several locations during dermostitch by interrupted suturing.There were no adverse consequences to the patient.

• Brand Name: PDS SUTURE 18"(45CM) 4-0 VIO
• 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: 7287902
• Report Number: 2210968-2018-70974
• Device Sequence Number: 16601088
• Product Code: NEW
• UDI-Device Identifier: 10705031029644
• UDI-Public: 10705031029644
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• 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): 02/07/2018

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: 09/30/2022
• Device Catalogue Number: D8252
• Device Lot Number: LLM879
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1