MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 3INX6IN; MESH, SURGICAL, POLYMERIC

Model Number PMII

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

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Hernia (2240); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

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 a ventral hernia repair surgery on (b)(6) 2014 and mesh was implanted.It was reported that the patient underwent a ventral hernia repair surgery on unk date and mesh was implanted.It was reported that the patient experienced mesh adhesion, infection, pain, inflammation, swelling, bowel obstruction, gastrointestinal malfunction, and hernia recurrence.The patient had a previous mesh implanted on unk date and another mesh implanted on (b)(6)2002,(b)(6) 2003, (b)(6) 2009 which are captured in separate files.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 2/3/2022.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: PROLENE MESH 3INX6IN
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13201426
• MDR Text Key: 286347751
• Report Number: 2210968-2022-00176
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031049024
• UDI-Public: 10705031049024
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K180829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: PMII
• Device Catalogue Number: PMII
• Device Lot Number: GKE728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2013
• 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: Male