MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC

Model Number PCDH1

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

Patient Problems Adhesion(s) (1695); Fistula (1862); Inflammation (1932); Necrosis (1971); Pain (1994); Perforation (2001); Scar Tissue (2060); Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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.(b)(4) submitted for the adverse event which occurred on (b)(6) 2012.(b)(4) submitted for the adverse event which occurred on (b)(6) 2017.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2008 and mesh was implanted.It was reported that the patient underwent revision surgery on (b)(6) 2012.It was reported that the patient underwent removal surgery on (b)(6) 2017.It was reported that the patient experienced severe and chronic pain/discomfort, inflammation, bowel perforation, bowel resection, infection, fistula, necrosis, scarring, dense adhesions, small bowel adherent to mesh, opening draining wound and abdominal wall reconstruction.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 10/31/2021.

Manufacturer Narrative

Date sent to the fda: 11/10/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11580185
• MDR Text Key: 251642758
• Report Number: 2210968-2021-02823
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047723
• UDI-Public: 10705031047723
• 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,Followup,Followup
• Report Date: 03/22/2021

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 Expiration Date: 01/31/2009
• Device Model Number: PCDH1
• Device Catalogue Number: PCDH1
• Device Lot Number: ABG086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 03/27/2021
• Supplement Dates Manufacturer Received: 10/28/2021; 11/10/2021
• Supplement Dates FDA Received: 10/31/2021; 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2008
• 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: 34 YR
• Patient Sex: Female