MAUDE Adverse Event Report: ETHICON INC. PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY; MESH, SURGICAL, POLYMERIC

Model Number PHSE

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

Patient Problems Hematoma (1884); Pain (1994); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Mwr-23062020-0000753341 submitted for adverse event which occurred on (b)(6) 2009.Mwr-23062020-0000753352 submitted for adverse event which occurred on an unknown date.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2009 and mesh was implanted.It was reported that the patient underwent bilateral hernia repair surgery and revision of the previously placed mesh on (b)(6) 2010 during which the surgeon noted evidence of a medium sized direct hernia and the previously placed mesh which he noted to have pulled away from the pubic tubercle and coopers ligament.It was reported that the patient underwent bilateral hernia repair surgery and revision of the previously placed mesh on a unknown date during which the surgeon noted a sizable hematoma in his left groin.Previously placed mesh was trimmed in a piecemeal manner until about roughly an inch was removed.It was reported that the patient experienced severe pain, mesh dissection, mesh removal, stress and anxiety.No additional information is provided.

Manufacturer Narrative

Date sent to the fda: 04/12/2021.Additional information: a1,a2, b7, d3.

• Brand Name: PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 10192362
• MDR Text Key: 197152208
• Report Number: 2210968-2020-04761
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031048935
• UDI-Public: 10705031048935
• Combination Product (y/n): N
• PMA/PMN Number: K180829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: PHSE
• Device Catalogue Number: PHSE
• Device Lot Number: 21077-46
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR