MAUDE Adverse Event Report: ATRIUM MEDICAL PROLOOP MESH; MESH, SURGICAL, POLYMERIC

Model Number 30901

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

A surgeon was performing an open inguinal hernia surgery and the package did not include an onlay.The hospital had another unit to appropriately perform the surgery.

Event Description

N/a.

Manufacturer Narrative

Analysis - the returned proloop mesh package was inspected to determine if the onlay was indeed missing from the package.Upon opening the box there was only i package.The proloop mesh are sold two to a box.The details provided indicate that the other sample was used in the procedure.The one package provided was still sealed and had not been opened.The product packaging on the back side is clear allowing for an easy visual inspection.Upon inspection the proloop plug was present but the mesh onlay was not present as described in the complaint details.Clinical evaluation - proloop mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material.When a product is brought to the surgical arena and prepared for use it is inspected to insure the integrity of the packaging, the expiration dates and confirmation of the correct product size and type, etc.Is conducted between two clinicians in accordance with the safe practice recommendations provided by the joint commission.If any discrepancies are discovered the product is rejected and a new one is prepared.This may represent a delay prior to patient contact while the second product is prepared.When this step is omitted, and a product within a defective package is used it would put the patient at increased risk for infection.The instructions for use (ifu) states complications that may occur with the use of any surgical mesh include, but are not limited to, pain, inflammation, infection, allergic reaction, seroma, hematoma, fistula formation or mechanical disruption of the tissue and/or mesh material and possibly adhesions when placed in direct contact with the viscera and other organs.The patient should be advised to contact the physician should an adverse reaction occur.

• Brand Name: PROLOOP MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7847428
• MDR Text Key: 119508815
• Report Number: 3011175548-2018-00974
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00862309010
• UDI-Public: 00862309010
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2023
• Device Model Number: 30901
• Device Catalogue Number: 30901
• Device Lot Number: 432041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Manufacturer Received: 08/28/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1