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 Seroma (2069); Urinary Retention (2119); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/31/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to clarify 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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? if so, please specify.Does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? (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: journal of family medicine and primary care volume 9 : issue 5 : may 2020.

Event Description

Title: does laparoscopic hernia repair affect the vascularity of testis? in this study, we attempt to evaluate the effects of laparoscopic total extraperitoneal (tep) repair on testicular blood flow in indian population by comparing the testicular perfusion in preoperative and postoperative.From january 2018 to january 2019, a total of 100 sides were operated in 80 patients.The average age of these patients was 50.2 ± 13.3 years (range 24¿72 years).Nearly 60 of these patients were clinically diagnosed to have a unilateral hernia (40 right-sided and 20 left-sided, 36 indirect, and 24 direct hernias) and 20 to have a bilateral hernia (36 direct and 4 indirect) (distribution of hernia [laterality] and type of hernia).Eventually, 60 patients underwent a unilateral repair and 20 patients underwent bilateral repair.A 15*13 cm sized prolene mesh was used in all cases.8 cases had peritoneal breach.1 case had urinary bladder injury that was detected on 1st postoperative day when the patient did not void after removal of the catheter, on ct scan a 3 mm rent was diagnosed on the anterolateral aspect, the patient was managed conservatively by reinserting 20 fr.Size foley catheter for 21 days.1 patient had inferior epigastric artery injury which was managed intraoperatively by monopolar coagulation.4 patients had pneumo scrotum which resolved within 48h, 2 patients had seroma which resolved within 4 weeks and 1 patient had urinary retention which required recatheterization.Tep repair is a safe procedure in an experienced hand, it does not hamper the vascularity of the testes, and care should be taken during a dissection of the hernia sac from the cord structure.Further studies with a bigger sample size and longer follow-up are required to evaluate the long-term effect.

Manufacturer Narrative

(b)(4).Date sent to the fda: 06/04/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following was obtained: does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? if so, please specify.Response: no.Does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Response: no.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Response: not applicable.Patient demographics?.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11710322
• MDR Text Key: 246810379
• Report Number: 2210968-2021-03664
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K962530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 06/04/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention