MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 60"(150CM) 2 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D7190
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.
Event or Problem Description
It was reported a patient underwent an unknown procedure on an unknown date and suture was used.During use break in the middle while tying the suture.No adverse patient consequences reported.

• Brand Name: PDS II SUTURE 60"(150CM) 2 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: 8174549
• Report Number: 2210968-2018-77838
• Device Sequence Number: 2640478
• Product Code: NEW
• UDI-Device Identifier: 10705031027350
• UDI-Public: 10705031027350
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2018

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 Catalogue Number: D7190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2018
• Initial Report FDA Received Date: 12/18/2018
• Patient Sequence Number: 1