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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Inflammation (1932); Pain (1994); Abdominal Distention (2601); Not Applicable (3189)

Event Date 08/06/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the 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.If in your possession, may we have copies of your operative reports (includes (b)(6) 2011 hernia repair, 2014 exploratory surgery performed by bariatric doctor)? does ethicon have your permission to contact your doctors/surgeon(s), in the event ethicon would like to contact your surgeons for more clinical information to be used for a product quality complaint investigation? the single complaint was reported with multiple events.There are no additional details regarding the additional events.This medwatch report is in response to receipt of maude report mw# 5093985.Events were submitted via 2210968-2020-03733.

Event Description

It was reported that the patient underwent laparoscopic 2 ventral hernia repair surgery on (b)(6) 2011 and the suture was used to fix unspecified brand mesh in two places.As reported, the patient woke up with pain and nausea which have never gone away.The patient experienced tight and pulling in colon, abdominal pain, pressure in stomach, gastric acids, pooching out stomach, pain in upper chest from pressure and pain in pelvic floor into groin.In 2014 the patient underwent an exploratory surgery.It was found that degrading unspecified brand mesh was laying loosely and sutures which supposed to be dissolved in 2-3 months were still present 3 years later.In 2019 the patient experienced severe abdominal distention and bloating of mid-section.It was also reported that the constant pressure pushes into her esophagus with additional continuous pain in groin and pelvic floor.Mid 2019, another ct scan has been performed showing thinning bowel walls in several places which is due to constant inflammation.As the patient reported, a tooth loss occurred over the last several years as there is biofilm caused by the bacteria coming up from her digestive system.In 2020, the patient has cramping, pain, green vaginal discharge, inflammation in vaginal area.She gained 30 pounds.The patient hardly eats due to the pain it causes.Pancreatic cysts are now growing, changing shape and were detected in lung and neck.Additional information has been requested.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10026910
• MDR Text Key: 191681711
• Report Number: 2210968-2020-03732
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2020
• 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