MAUDE Adverse Event Report: ETHICON INC. UNK_SUTURE UNKNOWN; SUTURE, SURGICAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

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.If contact information is provided the following information will be requested: if in your possession, may we have a copy of your mothers operative report to review the type of suture and which layer of tissue the suture was used? does ethicon have your permission to contact your mother¿s surgeon, in the event ethicon would like to contact the surgeon for more clinical information to be used for a product quality complaint investigation?.

Event Description

It was reported via twitter that a patient underwent a surgical procedure on an unknown date and suture was used.The patient experienced a blow out on her main aorta causing major complications and eventually death.No additional information was provided.

• Brand Name: UNK_SUTURE UNKNOWN
• Type of Device: SUTURE, SURGICAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8698434
• MDR Text Key: 147987215
• Report Number: 2210968-2019-82730
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/13/2019
• 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
• Patient Outcome(s): Death; Required Intervention