MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 1 S/A CTX; SUTURE, SURGICAL, ABSORBABLE

Catalog Number SXPP1A400

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2019

Event Type  malfunction  

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.Additional information was requested and the following was obtained: lot #? unk.Was any action taken on patient post-op to revise reported event? if yes, what? patient subjected to additional medical check.Was there any medical /surgical intervention/re-suturing/revision procedure performed on patient post-op? patient subjected to additional medical check.Patient current condition? discharged.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and a barbed suture was used.Following the procedure, the suture loosened.The tab of the suture loosened the tightening.There were no adverse patient consequences.The current condition of the patient was reported as discharged.No additional information has been provided.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A CTX
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; avenida de las torres 7125; col salvacar; cuidad juarez 32604 ; MX 32604
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8758386
• MDR Text Key: 149961514
• Report Number: 2210968-2019-83624
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031219366
• UDI-Public: 10705031219366
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SXPP1A400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1