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 Hemorrhage/Bleeding (1888); Pain (1994); Seroma (2069); Hernia (2240)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint #:(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:hernia (2019) 23:299¿303 https://doi.Org/10.1007/s10029-018-1869-y.

Event Description

It was reported via a journal article: title: feasibility of totally extraperitoneal (tep) laparoscopic hernia repair in elderly patients a retrospective study that reviewed clinical records of inguinal hernia patients who had undergone hernia repairs by experienced surgeons from august 2007 to september 2016.A total of 425 cases were documented.The patients were divided into two groups according to age: one group included 317 (74.6%) patients who were younger than 70 years and the other group included 108 (25.4%) patients those aged 70 years and older.The average follow-up period was 7 days after the surgery.A 10-mm blunt-tip trocar (ethicon)was inserted into the preperitoneal space with insufflation of carbon dioxide to a pressure of 10¿12 mmhg.Under direct endoscopic vision, a 5-mm trocar (ethicon) port was placed directly above the symphysis pubis.The extraperitoneal space was dissected and created by endodissectors with diathermy.Dissection of the hernia sac was performed to expose the spermatic cord/round ligament and all hernia orifices.After dissection of the inguinal region and reduction of the hernia sac was completed, a mesh prosthesis 12 × 9 or 13 × 10 cm, prolene mesh (ethicon) was inserted to cover all potential hernia orifices.The mesh fixation was done with endoscopic tacks.The patients were transferred to the postanesthesia recovery room for observation before returning to the hospital ward.The patients were usually discharged the next day.Reported postoperative complications in younger than 70 years patients bleeding (n=2) ,dysuria (n=20), seroma (n=6) and recurrence (n=1).Postoperative complications in aged 70 years and older bleeding (n=1) ,dysuria (n=11), seroma (n=1), recurrence(n=2).The length of hospital stay in elderly group was longer than that in the younger group.In conclusion laparoscopic tep hernia repair can be performed safely in elderly patients without differences in perioperative complications and recurrence rate compared to that in a younger population despite a longer hospital stay.

Manufacturer Narrative

Product complaint # (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.The following information was requested, but unavailable: 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?.

• 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: 11710649
• MDR Text Key: 263098134
• Report Number: 2210968-2021-03665
• 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

• Date FDA Received: 04/22/2021
• 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: 05/07/2021
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention