MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Migration (4003)

Patient Problems Adhesion(s) (1695); Erosion (1750); Hemorrhage/Bleeding (1888); Ischemia (1942); Perforation (2001)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2014 and mesh was implanted.It was reported that the patient underwent revision and removal surgery on (b)(6) 2021 during which the surgeon noted patient has strangulated small bowel hernia and sigmoid was attached to hernia plug.He noted they encountered adhesion of the sigmoid area to the hernia plug the strangulated bowel could be reduced without making the hernia defect bigger.The area of the distal jejunum was strangulated and the could not make the opening bigger without releasing the sigmoid and removing the plug.By the time the strangulated bowel dropped in the peritoneal cavity noticed ischemic bowel with perforation and noticed blood was coming from the hernia cavity where the bowel was strangulated.Ischemic bowel as on the top of the femoral vein that was eroded.We were able to identify the source of the bleeding and he was able to repair the left femoral vein.The patient had massive blood loss.The patient underwent a blood transfusion.It was reported that the patient underwent recurrent hernia repair surgery on (b)(6) 2021 during which the surgeon noted significant adhesions and obliteration of the preperitoneal planes, obliteration of the typical inguinal planes.It was reported that the patient experienced an unknown adverse event.No additional information was provided.

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.(b)(4) submitted for adverse event which occurred on (b)(6) 2021.(b)(4) submitted for adverse event which occurred on (b)(6) 2021.

Manufacturer Narrative

Date sent to the fda: 09/15/2022.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• 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: 14467453
• MDR Text Key: 294767626
• Report Number: 2210968-2022-03916
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962530
• 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: 05/22/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 05/22/2022
• Supplement Dates Manufacturer Received: 09/15/2022
• Supplement Dates FDA Received: 09/15/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female