MAUDE Adverse Event Report: ETHICON INC. MERSILENE TAPE UNKNOWN PRODUCT; INSTRUMENT, SURGICAL, DISPOSABLE

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

Patient Problems Abscess (1690); Erosion (1750); Purulent Discharge (1812); Edema (1820); Pain (1994); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: was the case discussed in this article previously reported to ethicon? we had not reported this to ethicon.Does the surgeon believe that ethicon products (mersilene tape) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products (mersilene tape) used in this procedure? the tape might have been responsible for this mesh erosion.Any added infection might have contributed to this.There was no clinical evidence of any infection post operatively but patient started complaining of pelvic pain after one week.This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: j gynecol surg 34:248; doi: 10.1089/gyn.2018.0010.[(b)(4)].

Event Description

It was reported via journal article: "title: a unique case of rectosigmoid mesh erosion presenting as left thigh sinus tract abscess following laparoscopic sacrocervicopexy" author(s): p.G.Paul, mbbs, dgo, hemant shintre, mbbs, dgo, dnb, gunjan gulati, mbbs, ms, sumina mannur, mbbs, ms, dnb, george paul, mbbs, ms, and santwan mehta, mbbs, ms citation: j gynecol surg 34:248; doi: 10.1089/gyn.2018.0010.This study aimed to present a (b)(6) multiparous woman who underwent laparoscopic shirodkar¿s sacrocervicopexy.In the procedure, one end of mersilene tape had been fixed to the anterior longitudinal ligament, then passed subperitoneal along the right pelvic wall between the two leaves of the broad ligament, and transfixed to isthmus posteriorly.The tape had been then passed posteriorly through the left broad ligament and taken out through the psoas loop on the left side.The tape had been finally fixed to the anterior longitudinal ligament after passing it beneath the sigmoid mesentery.Postoperatively, she had intermittent pain in her left leg and left thigh region managed with analgesics.Three years later, she presented a left thigh abscess and pus discharge which was incised and drainage was performed.She was also given course of antibiotics.Despite this, the pus persisted.Three months later, she was diagnosed with pelvic abscess with a left lateral thigh sinus tract with the possibility of mesh erosion.In ultrasonography, there was also mild subcutaneous edema.Total laparoscopic hysterectomy and bilateral salpingectomy with excision of the sinus tract abscess was planned.During the procedure, rectosigmoid mesh erosion was identified and was managed by excision of the mesh with closure of the sinus tract, and bowel diversion and repair.Postoperatively, she was given broad spectrum antibiotics coverage for 7 days.Inflammation with infection might have been the possible cause of the rectosigmoid colon mesh erosion and left thigh sinus-tract abscess.The kind of mesh (mersilene tape) and the mesh load might have been the contributing factors.

• Brand Name: MERSILENE TAPE UNKNOWN PRODUCT
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• 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: 8392672
• MDR Text Key: 137934939
• Report Number: 2210968-2019-79284
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• 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: 02/14/2019
• 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): Required Intervention
• Patient Age: 41 YR