MAUDE Adverse Event Report: ETHICON INC. NYLON SUTURE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994); Seroma (2069); Obstruction/Occlusion (2422); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: vicryl suture, evicel fibrin sealant, arista ah, no.19 closed-suction round drains, quill 3.0 monoderm.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.(b)(4).

Event Description

It was reported in a journal article that the patient underwent an open complex abdominal ventral hernia repair with intraperitoneal and retrorectal placement of a human acellular dermal matrix and bilateral component separation on unknown date between 07/2011 and 07/2013 and the suture was used to secure a closed-suction round drain placed percutaneously.It was also reported that drains were removed after seven or ten days and/or when the output was less than 20 cc daily.Following the procedure, the patient experienced a wound infection.It was resolved with a course of oral antibiotics and/or treated with incision and drainage of the wound.It was also reported that the patient experienced seroma formation and ileus.Additional information has been requested.

• Brand Name: NYLON SUTURE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: kenneth clark ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183547
• MDR Report Key: 5804970
• MDR Text Key: 49911068
• Report Number: 2210968-2016-10582
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FLEXHD MESH, PDS SUTURE,
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR