MAUDE Adverse Event Report: ETHICON INC. PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY; MESH, SURGICAL, POLYMERIC

Model Number PHSM

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

Patient Problems Pain (1994); Hernia (2240); Numbness (2415)

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) 2015 and mesh was implanted.It was reported that the patient underwent removal surgery, left genital branch genitofemoral neurectomy, left ilioinguinal neurectomy, left iliohypogastric neurectomy and recurrent left inguinal hernia repair surgery on (b)(6) 2019 during which the surgeon noted he dissected the inferior flap of the external oblique aponeurosis freeing it completely off the underlying mesh.He had to take some of the external oblique aponeurosis as it was densely adherent to the mesh.Medially, the cord was dissected off of the mesh.A branch of genitofemoral nerve was lying on the mesh.This was dissected free and it was also ligated proximally and distally.The shelving edge of the inguinal ligament along the most lateral portion of the mesh was identified.He dissected the cord off of the mesh medially.He then dissected the superior edge of the mesh elevating it off of the conjoined tendon, dissecting down toward the cord structures.The mesh was noted to be bulky around the internal ring in passage of the cord structures.The mesh was unraveled, freed from the shelving edge of the inguinal ligament and removed.It was reported that the patient experienced severe pain, burning, nerve damage, numbness stress and anxiety.No additional information was provided.

Manufacturer Narrative

Date sent to the fda: 1/8/2021.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

Date sent to the fda: 08/12/2021.

• Brand Name: PRLNE HERNIA SYSTEM MSH 7.5CM UNDERLAY
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11136598
• MDR Text Key: 226325747
• Report Number: 2210968-2021-00139
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031048997
• UDI-Public: 10705031048997
• Combination Product (y/n): N
• PMA/PMN Number: K180829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: PHSM
• Device Catalogue Number: PHSM
• Device Lot Number: 2838104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR