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 Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 hernia repair surgery on (b)(6) 2007 and two (2) mesh products were implanted.It was reported that the patient underwent removal surgery on (b)(6) 2014 during which the surgeon noted meshoma with both previously placed pieces of infected mesh, abdominal wall debridement including skin, subcutaneous tissue, muscle and fascia.He performed a wedge resection of the right lobe of the liver that was involved intimately with epigastric meshoma.It was reported that the patient experienced severe pain and inflammation.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 7/27/2022.H6: appropriate term / code not available (e2402) utilized to capture meshoma.Additional b5 narrative: it was reported that the patient experienced adhesions, abscess, meshoma, obstruction, hernia recurrence.Date sent to the fda: 7/27/2022.

Manufacturer Narrative

Date sent to the fda: 08/21/2022.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.; route 22 west; somerville NJ 08876
• 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: 14672993
• MDR Text Key: 293911721
• Report Number: 2210968-2022-04491
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 06/30/2008
• Device Model Number: PCDH1
• Device Catalogue Number: PCDH1
• Device Lot Number: ZHG458
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female