MAUDE Adverse Event Report: HERNIA SURGICAL MESS IMPLANT; HERNIA SURGICAL MESH IMPLANT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Purulent Discharge (1812); Nerve Damage (1979); Pain (1994); Swelling (2091); Hernia (2240)

Event Date 08/29/2013

Event Type  Injury  

Event Description

Reporter states that, on (b)(6) 2013, he was diagnosed by his primary care physician with inguinal hernia.He was then referred to a surgeon dr.(b)(6) who upon consultation did not find any immediate concern.Reporter says his pain became unbearable and consultation with dr.(b)(6) was not possible as he never answered his phone.He then decided to consult with his primary care physician who then got hold of dr.(b)(6).And on (b)(6) 2013, through his primary care physician, he received a call from dr.(b)(6) who instructed him to check-in at (b)(6) hospital and was operated upon same day at about 9pm.He had a visit from the chief surgeon; dr.(b)(6) few hours after his operation.He told him he had strangulated(incarcerated)hernia and that a mesh was placed because of the largeness of the sac.Reporter states that dr.(b)(6) said the delay for the surgery caused the strangulation.Two days post surgery, reporter says his scrotal sac was seriously swollen about the size of a softball.Reporter says dr.(b)(6) told him dr.(b)(6) did not do the surgery well which is why his scrotal sac was filled with blood.Reporter says he was discharged on day two post surgery.Approximately two weeks post surgery, he was seen by the surgeon dr.(b)(6).Reported says dr.(b)(6) made a hole about 2.7cm in size around his penis and extracted the blood and pus.Reporter says he had four months of home visitation nursing for changing and dressing of the wound.In (b)(6) 2014, reporter says he visited dr.(b)(6) in his office due to severe pain.He said dr.(b)(6) referred him to (b)(6) hospital for the removal of the mesh.Mesh was removed on (b)(6) 2014.Reporter says he was asked to see a neurologist because of permanent nerve damage caused by dr.(b)(6) surgery.Reporter says he was seen by a neurologist in 2015 who performed a nerve test.Reporter says the nerve test proved that he indeed has an irreversible nerve damage in his groin.Reporter says he is on pain medication regimen with impaired mobility.Reporter says his life is ruined by dr.(b)(6).

• Brand Name: HERNIA SURGICAL MESS IMPLANT
• Type of Device: HERNIA SURGICAL MESH IMPLANT
• MDR Report Key: 5892957
• MDR Text Key: 52847094
• Report Number: MW5064216
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/18/2016

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: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 67 YR
• Patient Weight: 86