MAUDE Adverse Event Report: ETHICON INC. ETHILON BLUE NYLON SUTURE; SUTURE, NONABSORBABLE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Irritation (1941); Itching Sensation (1943); Rash (2033); Swelling (2091); No Code Available (3191)

Event Date 07/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent to the fda: 08/17/2016.(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.What was the date of the initial procedure? what was the condition of the tissue where the ethilon was placed? how was the suture used (continuous or interrupted technique)? what are the patient medical conditions/ indication for the procedure? can you identify the product code and lot number of ethilon suture used? can you describe the patient initial post operative period? what date did the issue begin after the procedure? were photos taken of the patient symptoms of reaction? what was the surgeon opinion regarding the symptoms and reaction? is it standard practice to remove subcutaneous sutures 10 days post op? did the patient receive any medical treatment for your symptoms? what was prescribed by the surgeon? please provide the patient age, body weight and medical history at the time of this surgical procedure.What is the patient current status?.

Event Description

It was reported that the patient underwent a pacemaker surgical procedure on unknown date ten weeks ago and the suture was used for subcutaneous tissue.At around five and half weeks following the procedure, the skin became lumpy in an oval around the suture line and at six- seven weeks a rash appeared across the chest and then arms, neck and face.The patient experienced a skin irritation and her face became itchy and swollen.It was also reported that ten days after surgery, the suture was removed.Additional information has been requested.

• Brand Name: ETHILON BLUE NYLON SUTURE
• Type of Device: SUTURE, NONABSORBABLE
• 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: 5882526
• MDR Text Key: 52318089
• Report Number: 2210968-2016-11368
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• 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: 07/26/2016
• 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: VICRYL SUTURE
• Patient Outcome(s): Required Intervention