MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION MESH PROLITE ULTRA SHEETS; MESH, SURGICAL, POLYMERIC

Model Number 30715

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

Patient Problems Pain (1994); Urinary Tract Infection (2120); Hernia (2240)

Event Date 07/15/2014

Event Type  Injury  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

Event Description

Report received from therapeutic goods administration (tga) that a male patient had hernia repair implanted with prolite mesh.Shortly after noticed blood in semen, developed a uti, cleared with antibiotics.Later experienced interrupted ejaculation with dysfunction of nerve/muscle, preventing ejaculation.Hip pain and localized pain in implant area and hernia recurrence.

Manufacturer Narrative

Based on the details of the complaint the patient who had the mesh implanted in 2014 shortly after noticed blood in semen, developed a uti, cleared with antibiotics.Later experienced interrupted ejaculation with dysfunction of nerve/muscle, preventing ejaculation.Hip pain and localized pain in implant area and hernia recurrence.No other details will or were provided including the reason for the mesh implantation and the condition of the patient prior to the placement of the hernia mesh.No operative notes were provided or doctor follow up notes with any type of analysis or confirmation of the patient conditions and therefore the complaint cannot be confirmed.There is no evidence provided that indicates that the mesh was the reason for the patients conditions.Within the instructions for use (ifu) the following is stated in the adverse reaction section of the ifu: adverse reactions: complications that may occur with the use of any surgical mesh include, but are not limited to, inflammation, infection or mechanical disruption of the tissue and/or mesh material, possible adhesions when placed in direct contact with the viscera (intestines).The ifu also states the following in regards to operative technique in the warnings and precautions section the following: "warnings 1.Do not re-sterilize surgical mesh that has been in contact with or contaminated by blood or other substances.2.Avoid direct contact with the viscera (intestines) to minimize the possibility of adhesions.3.Adequate mesh fixation is required to minimize post operative complications and recurrence.The fixation technique, method, and products used (including sutures, tacks, staples or other means) is left to the discretion of the surgeon to optimize clinical outcomes.Precautions: 1.Handling of mesh should be with clean, sterile gloves and/or instruments.2.Careful attention to surgical mesh handling, suture, staple, or tacker fixation is required in the presence of nerves and vessels in the surgical field".A review of the device history records does not indicate that this lot of mesh was non-conforming.All quality and performance requirements were met based on the review.The sterility records for this lot of mesh was also conducted.The review did not identify any non-conformances during this review that would indicate that the sterilization was not conducted or effective.Also included in the device history records review were the sub assembly components of the material including the incoming inspection of the mesh raw material.The review indicated that the mesh material met all quality and performance criteria at the incoming inspection level.Based on the investigation and review of the device history records there is no indication that the device was non-conforming and it met all product and quality requirements.

Event Description

N/a.

• Brand Name: MESH PROLITE ULTRA SHEETS
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• MDR Report Key: 11682683
• MDR Text Key: 245965790
• Report Number: 3011175548-2021-00416
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00650862307153
• UDI-Public: 00650862307153
• Combination Product (y/n): N
• PMA/PMN Number: K002093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: 30715
• Device Catalogue Number: 30715
• Device Lot Number: 10907358
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention