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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELA BIO, INC. OVITEX1S ABSORBABLE MESH MESH, SURGICAL

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TELA BIO, INC. OVITEX1S ABSORBABLE MESH MESH, SURGICAL Back to Search Results
Device Problems Entrapment of Device (1212); Unexpected Therapeutic Results (1631)
Patient Problems Dysphagia/ Odynophagia (1815); Scar Tissue (2060); Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)
Event Date 02/21/2020
Event Type  Injury  
Event Description
Hiatal hernia surgery using ovitex 1s mesh, along with a tif procedure, (b)(6) 2020. When the time to eat solid food came, i was not able to swallow food. For 10 months had to eat soft or mainly liquids. The surgeon found mesh and sutures embedded inside my esophagus in (b)(6) 2020 during a fourth egd to dilate my esophagus. It was surgically removed, but still had problems swallowing. Had 4 tif fasteners removed (b)(6) 2021. Had barium swallow (b)(6) 2021 which showed no change in the ability to swallow food. I've had 2 surgeons report that the mesh has damaged my esophagus, and i need an esophagectomy. And one surgeon who says that i need to robotically have scar tissue removed and a toupet to completely reverse the tif procedure. This was absorbable mesh and silk sutures. I've had many tests and a total of 8 doctors trying to rectify this situation. The mesh is still inside of me as it is absorbable. Two different surgeons have found silk sutures inside my esophagus, one (b)(6) 2020, another (b)(6) 2021. Fda safety report id # (b)(4).
 
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Brand NameOVITEX1S ABSORBABLE MESH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
TELA BIO, INC.
MDR Report Key15043780
MDR Text Key296171991
Report NumberMW5110924
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 07/15/2022 Patient Sequence Number: 1
Treatment
AMLODIPINE; CENTRUM SILVER ; LEVOTHYROXINE; LISINOPRIL ; METOPROLOL ; NORTRIPTYLINE ; PANTOPRAZOLE; ROSUVASTATIN ; VITAMIN D
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