MAUDE Adverse Event Report: ETHICON INC. PROCEED MESH 6INX6IN(15CMX15CM) SQ; MESH, SURGICAL, POLYMERIC

Model Number PCDM1

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); Hernia (2240); 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.

Event Description

It was reported by an attorney that the patient underwent removal surgery on (b)(6) 2014 and mesh was implanted during which the surgeon noted extensive adhesions and a hernia recurrence.It was reported that the patient underwent a surgical procedure on (b)(6) 2014 during which a wound vac was placed.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) 2011 and (b)(6) 2012 which is captured in a separate files.No additional information was provided.

• Brand Name: PROCEED MESH 6INX6IN(15CMX15CM) SQ
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14164725
• MDR Text Key: 289736462
• Report Number: 2210968-2022-02831
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047754
• UDI-Public: 10705031047754
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PCDM1
• Device Catalogue Number: PCDM1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Female