MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ VIO 18IN 0 S/A CT-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	05/10/2019
Type of Reportable Event	Serious Injury
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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Can you identify the lot # ? what is the procedure name ? did the patient experience a post-op device malfunction ? any patient consequence /ae outcome as a result of the event report ? what was the quantity of blood loss ? was the patient re-admitted to hospital for blood loss ? was any medical /surgical intervention /transfusion performed on patient post-op? patient current condition ?.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on unknown date in 2019 and barbed suture was used.The suture was used on fascia and intercostal muscle together.On (b)(6) 2019, the patient experienced bleeding.An additional procedure was performed on an unknown date.The surgeon opined that the tab hurt the small branch of muscle.Additional information will be requested.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: SFX SYM PDS+ VIO 18IN 0 S/A CT-2
• 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: 8689212
• Report Number: 2210968-2019-82635
• Device Sequence Number: 2359390
• Product Code: NEW
• UDI-Device Identifier: 10705031227644
• UDI-Public: 10705031227644
• Combination Product (Y/N): N
• PMA/510(K) Number: K113004
• 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,Followup
• Report Date (Section B): 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: SXPP1A407
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 08/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention