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 Problem 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.Citation: journal of the college of physicians and surgeons pakistan.2009; vol.19 (12): 763-767.(b)(4).

Event Description

It was reported via journal article: "title: open extraperitoneal mesh repair for abdominal wall hernias in females" author/s: badar murtaza, naser ali khan and imran bashir malik* citation: journal of the college of physicians and surgeons pakistan.2009; vol.19 (12): 763-767.The objectives of this quasi-experimental study was to determine the outcome of treatment in terms of infection and recurrence using open extraperitoneal mesh repair technique.A total of 32 cases (all female patients; mean age: 41.25 ± 10.79 years) with abdominal wall hernias with defect of 4 cm or more were studied.During the surgical procedure, once adequate extraperitoneal space had been created, this layer was closed in the midline by continuous vicryl 2-0 sutures (ethicon).It was then washed with normal saline and redivac suction drain(s) was placed over the prolene mesh (ethicon).In all the cases, polypropylene mesh was placed over this layer and secured with interrupted vicryl 2-0 sutures (ethicon).The superficial layers were then closed accordingly with vicryl 2-0 (ethicon) in the subcutaneous fat and prolene 3-0 (ethicon) over the skin.Reported complication included one morbidly obese patient with superficial wound infection and was treat with intravenous antibiotics.In this study, extraperitoneal mesh repair was found to be a successful proceeding in the abdominal wall hernias in females.Abdominal wall hernia are common in female patients with a history of previous surgical intervention.Open extraperitoneal mesh repair with placement of redivac drains is an effective method for the management of abdominal wall hernias with a low complication rate and low recurrence even in large hernial defects.

• 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.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8913490
• MDR Text Key: 155043433
• Report Number: 2210968-2019-85879
• 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,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2019
• 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