MAUDE Adverse Event Report: ETHICON INC. ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL; MESH, SURGICAL, POLYMERIC

Catalog Number PHY1520V

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

Patient Problems Diarrhea (1811); Nausea (1970); Pain (1994)

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 adverse event which occurred on (b)(6) 2012.(b)(4) submitted for adverse event which occurred on (b)(6) 2014.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2012 during which the surgeon noted her mesh that was on the superior aspect of the recurrent incision hernia had separated from the left superior portion of the hernia and within the hernia itself.As it was crumpled up, the peritoneal aspect of the mesh was mobilized using harmonic and unruffled from the hernia sac itself.The mesh continue to roll back into the patient¿s hernia sac and explanted the portion of her mesh that continued to roll up into the hernia sac itself.It was reported that the patient underwent removal surgery on (b)(6) 2014.It was reported the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite and extreme weight loss.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 03/22/2021.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: ETHICON PHYSIOMESH COMPOSITE MESH 15X20CM OVAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11467877
• MDR Text Key: 239464767
• Report Number: 2210968-2021-02291
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K093932
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Catalogue Number: PHY1520V
• Device Lot Number: DL8DGTA0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention