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

Model Number PCDH1

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Adhesion(s) (1695); Cellulitis (1768); Pain (1994); Scar Tissue (2060); Obstruction/Occlusion (2422); 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.

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2004 and mesh was implanted.It was reported that the patient underwent removal surgery on (b)(6) 2020 during which the surgeon noted ¿a large piece of mesh had come free from the abdominal wall and had scarred into the abdominal wall mesentery and had grown into the lumen of the small bowel.He had to resect about 1.5 feet of small bowel and removed the mesh that was adhered to the bowel and abdominal wall as well as some mesh that was adhered to the mesentery.¿ it was reported that the patient experienced constant pain, abdominal distention, bulging, gi irregularities, limited movement, difficulty standing and sitting for long periods of time, lifting restrictions, cellulitis, anxiety and depression.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 10/26/2022.H6: appropriate term / code not available (e2402) utilized to capture mesh migration.Additional b5 narrative: it was reported that the patient experienced bowel obstruction, mesh migration.

• 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 ; 9083863534
• MDR Report Key: 15271443
• MDR Text Key: 298389584
• Report Number: 2210968-2022-06815
• 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
• Report Date: 08/22/2022

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: PCDH1
• Device Catalogue Number: PCDH1
• Device Lot Number: T3G355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2022
• Initial Date FDA Received: 08/22/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 10/26/2022
• 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 Age: 34 YR
• Patient Sex: Male