MAUDE Adverse Event Report: HIATAL HERNIA MESH; MESH, SURGICAL

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problems Dyspnea (1816); Failure of Implant (1924); Memory Loss/Impairment (1958); Pain (1994); Dizziness (2194); Dysphasia (2195); Shaking/Tremors (2515); Blood Loss (2597); No Code Available (3191)

Event Date 08/24/2008

Event Type  Injury  

Event Description

Patient reported that she was diagnosed with a hiatal hernia in 2008.She alleged that her doctor informed her the he would repair it using a stomach full wrap.After waking up from her surgery her hands and mouth were shaking and she could not talk.She was also salivating from the left side of her mouth.She was informed that the symptoms would subside and was discharged.The next day, she began to have the following symptoms: dizziness, off-balanced, continued salvation, forgetfulness, dry mouth, continuous coughing and sob.She went to the dr 2 days later and she was told that these side effects could be due to her bp medication.She went to a second dr a week later.She stated that this dr did not agree that it was the bp medication but would not give her a diagnosis.Her symptoms persisted.In 2014, she went to pick something up form the floor and felt excruciating pain.She began to bleed heavily through her anus.She said that the smell was horrible almost like a "died body".She went to the emergency room.The emergency room and was told that they had to remove a few polyps and the bleeding would stop eventually.According to the pt the bleeding did not stop.She had to wait for 1 year before she could get an additional upper gi surgery as medicare would not pay for a second one until that time.In 2015, when she had the surgery she was told by a "student" dr that she had 2 masses or tumors.She did not believe that to be true and sought a second opinion.The next dr told her he was the friend/teacher of her previous drs and that once he opened her up found nothing wrong.She alleged that he was covering up for the other doctors.Last year she found out that her hiatal hernia was actually repaired with mesh and not the stomach full wrap.That it broke in several pieces and one landed on her kidney causing her incontinence.She has allergies to plastics and believes that the mesh has caused all of her symptoms.

• Brand Name: HIATAL HERNIA MESH
• Type of Device: MESH, SURGICAL
• MDR Report Key: 9468274
• MDR Text Key: 171542726
• Report Number: MW5091670
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• 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: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 66 YR
• Patient Weight: 65