MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUTURE 30"(75CM) 6-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP127H
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).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.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 that a patient underwent an unknown child procedure on an unknown date and the suture was used.During usual manipulation with simple traction, the thread was cut.There were no adverse patient consequences reported.

• Brand Name: PDS PLUS SUTURE 30"(75CM) 6-0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9857608
• Report Number: 2210968-2020-02245
• Device Sequence Number: 11481819
• Product Code: NEW
• UDI-Device Identifier: 10705031047907
• UDI-Public: 10705031047907
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 02/25/2020

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 Expiration Date: 09/30/2020
• Device Model Number: PDP127H
• Device Catalogue Number: PDP127H
• Device Lot Number: MLM026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/19/2020
• Patient Sequence Number: 1
• Patient Age: 6 YR