MAUDE Adverse Event Report: ETHICON INC. PROLENE* POLYPROPYLENE MESH; MESH, SURGICAL, POLYMERIC

Model Number PML

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

Patient Problems Adhesion(s) (1695); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Chills (2191); Weight Changes (2607); Decreased Appetite (4569)

Event Type  Injury  

Manufacturer Narrative

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.(b)(4) submitted for the adverse event which occurred on (b)(6) 2014.(b)(4) submitted for the adverse event which occurred on (b)(6) 2016.

Event Description

It was reported by an attorney that the patient underwent removal surgery of the mesh and hernia repair surgery on (b)(6) 2013 and mesh was implanted during which the surgeon noted ¿the found extensive adhesions of the small bowel to the mesh which had not incorporated into the abdominal wall.Lysis of adhesions was performed for over an hour.¿ it was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2014 during which the surgeon noted ¿he found the mesh floating in the hernia sac and it had detached from one side of the abdominal wall.The mesh was partially resected after adhesiolysis was performed to dissect it from the abdominal wall.¿ it was reported that the patient underwent lysis of adhesions and resection of foreign body mesh on (b)(6) 2016 during which the surgeon noted ¿he performed adhesiolysis to free the small intestine from the abdominal wall and resected the remainder of the mesh that was stuck to the inferior aspect of the rectus fascia.The intestine was completely excluded.¿ it was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, and extreme weight loss.The patient had a previous mesh implanted on (b)(6) 2009 which is captured in separate file.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 09/14/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to the fda: 11/25/2021.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12307068
• MDR Text Key: 266015895
• Report Number: 2210968-2021-07230
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031049031
• UDI-Public: 10705031049031
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Model Number: PML
• Device Catalogue Number: PML
• Device Lot Number: BEG268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male