MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

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

Patient Problems Abscess (1690); Hernia (2240); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation of article: razzaq ma, iqbal mt, shahab a.Determine the outcomes of external rectal prolapse med forum 2019;30(10): 96-98.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.  were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that the ethicon product (prolene mesh) 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 product involved?.

Event Description

It was reported in a journal article with title: determine the outcomes of external rectal prolapse.This observational study was conducted at department of general surgery, bhatti international teaching hospital and central park hospital, lahore from 01-06- 2016 to 30-11-2017.Thirty patients of both genders were selected for this study out of 30 patients,22 (73.33%) were male patients and 8 (26.67%) were females.Five patients were ages <20 years, 13 patients were ages between 21 to 30.Years, 6 patients were ages 31 to 40 years, 3 patients had ages 41 to 50 years and 3 had ages above 50 years.Patients with complete rectal prolapse and above the age of 12 years were included in this study.All 30 patients with lower gastrointestinal symptoms e.G.Pain, something coming out from anus, bleeding per rectum and tenesmus were diagnosed on basis of history and examination including proctosigmoidoscopy.Patients were kept on clear fluids a day before the surgery and mechanical bowel preparation was done.Anterior resection, thieresch stitch and wells abdominal rectopexy was performed and prolene mesh (ethicon) was utilized.Reported postopertaive complications included constipation (n=6), wound infection (n=2), pelvic abscess (n=2) and recurrence (n=1).In conclusion technically feasible procedure is wells abdominal rectopexy with nil rate of reappearance, improved continence and shorter hospital stay in most patients.Continence grade in patients significantly increase and constipation is treated successfully with enriched fiber diet and use of bulk forming agents.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11750665
• MDR Text Key: 264142030
• Report Number: 2210968-2021-04077
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• 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: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention