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 Hematoma (1884); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

(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.Attempts are being made to obtain the following information.If further details are received at the 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 ethicon products 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 used in this procedure? citation: jpma 67: 24; 2017 (b)(4).

Event Description

It was reported via journal article "title: hernioplasty: tension free mesh repair versus mayo¿s repair for umbilical hernias" author: nazir ahmed tunio; citation: jpma 67: 24; 2017.This comparative study aimed to compare two different techniques of repairing umbilical hernia.From apr 2009 to dec 2011, 86 patients (n=18 male and n=68 female; age ranged of 25-65 years) with umbilical hernias were randomly allocated group a ¿ tension free mesh repair (n=43) and group b ¿ mayo¿s repair (n=43).In group a, prolene mesh was used to cover the defect and placed over the anterior rectus sheath, anchored by prolene 2/0 in an onlay fashion.In group b, classical steps were applied in which transverse double-breasting repair with non-absorbable suture material prolene no 1 was used.Postoperatively, complications included seroma (n=3 group a; n=1 group b), haematoma (n=1 group a; n=2 group b) and wound infection (n=2 group a; n=4 group b); which were all managed conservatively.On both groups, recurrence (n=1 group a; n=3 group b) was also noted after follow-up of 36 months.On the basis of short hospital stay, early return to normal activity, overall minimum complications and less recurrence rate, the tension free mesh repair was found to be superior than mayo's repair.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: 7936191
• MDR Text Key: 122803394
• Report Number: 2210968-2018-76329
• 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: Physician
• Type of Report: Initial
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• 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?: Yes
• Date Manufacturer Received: 09/10/2018
• 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