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 Inflammation (1932); 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-17122018-0000277351 submitted for adverse event which occurred on (b)(6) 2007.   mwr-17122018-0000277352 submitted for adverse event which occurred on (b)(6) 2018.   mwr-17122018-0000277353 submitted for adverse event which occurred on (b)(6) 2018.   in addition, a device history review has been inserted into the file. This review indicates that there was no quality concerns associated with the manufacturing process.

Event Description

It was reported by an attorney that the patient underwent inguinal hernia repair surgery on (b)(6) 2007 and mesh was implanted. It was reported that the patient underwent a right groin exploration and excision of scar on (b)(6) 2007 during which granulation tissue was noted in the area, which was excised, including a portion of the mesh. It was reported that the patient underwent additional mesh revision surgeries on (b)(6) 2018 and (b)(6) 2018. It was reported that the patient experienced severe pain and increasing inflammation. No additional information is provided.

Manufacturer Narrative

Date sent to the fda: 12/9/2021.

• 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 0151
• Manufacturer (Section G): J-PAC; 25 centre road; somersworth NH 03878 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8198967
• MDR Text Key: 131482644
• Report Number: 2210968-2018-77802
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/31/2011
• Device Model Number: PHSE
• Device Catalogue Number: PHSE
• Device Lot Number: 15940-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/27/2018 Patient Sequence Number: 1