MAUDE Adverse Event Report: ETHICON INC. PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY; MESH, SURGICAL, POLYMERIC

Model Number PHSL

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

Patient Problems Abscess (1690); Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

It was reported by an attorney that the patient underwent hernia repair surgery on (b)(6) 2006 and mesh was implanted.It was reported that the patient was admitted to the hospital with severe abdominal pain during which it was noted a large umbilical hernia protruding through 8.5 cm abdominal wall defect containing loops of dilated colon and small bowel; stranding mesenteric and small amount of fluid within the hernia sac, consistent with partial closed-loop bowel obstruction.It was reported that the patient underwent removal surgery on (b)(6) 2013 during which the surgeon noted small bowel incarcerated in the recurrent hernia sac and densely adhered to the previously placed mesh and it appeared that the mesh had eroded into the bowel causing some contamination of mesh.He freed the bowel from the mesh and removed the mesh in its entirety and resected the segment of bowel that had been adhered to the mesh.He tediously freed omentum incarcerated the hernia sacs, performed bilateral component separation and repaired the recurrent hernia.It was reported that the patient underwent drainage of a large and complex abscess deep into the midline incision on (b)(6) 2013.It was reported that the patient underwent additional drainage of purulent fluid on (b)(6) 2013.It was reported that the patient was hospitalized from (b)(6) 2013-(b)(6) 2013.It was reported that the patient experienced severe pain and discomfort.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) 2013.(b)(4) submitted for adverse event which occurred on (b)(6) 2013.(b)(4) submitted for adverse event which occurred on (b)(6) 2013.

• Brand Name: PRLNE HERNIA SYSTEM MSH 10CM UNDERLAY
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): J-PAC; 25 centre road; somersworth NH 03878
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12793352
• MDR Text Key: 282558267
• Report Number: 2210968-2021-11274
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031048966
• UDI-Public: 10705031048966
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PHSL
• Device Catalogue Number: PHSL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2021
• 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 Sex: Male