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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN IMPLANTABLE SURGICAL MESH MESH, SURGICAL, POLYMERIC

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UNKNOWN IMPLANTABLE SURGICAL MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Fever (1858); Pain (1994); No Code Available (3191); Constipation (3274)
Event Date 11/02/2018
Event Type  Injury  
Event Description

Early (b)(6) 2014 i had surgery for spigelian hernia, lower right abdomen. Surgical mesh was used to close hernia. Since then, had intermittent lower right abdominal pain, usually tolerable with otc pain reliever. (b)(6) 2018 i started having worsening pain in right lower abdomen, low grade fever. Went to emergency room, had ct scan. Kept overnight for observation and pain control. Work up for appendicitis. Sent home (b)(6)with pain meds and follow up instructions. Pain continued at various levels for next week, symptoms mimic acute appendicitis. Primary physician ordered 2nd ct scan. Pain and appendicitis symptoms continue. Back to emergency room (b)(6) due to a fall caused by sudden increase in pain. Xrays and ct scan done, ct scan negative for appendicitis. Sent home with diagnoses of constipation. On (b)(6) 3rd trip to emergency room for same symptoms but increasing pain. Surgical consult, another ct scan ordered but still no indication of appendicitis. (b)(6) taken to surgery for diagnostics laparotomy, after 30 minutes of lysing adhesions surgeon found my inflamed appendix plastered to the mesh that was used to repair the spigelian hernia. Appendix apparently migrated up to the mesh, where it adhered and became inflamed, giving me a 16 day bout of appendicitis. Appendix was never visualized on ct because it had migrated and adhered to mesh, delaying my diagnosis and treatment. Fda safety report id # (b)(4).

 
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Brand NameIMPLANTABLE SURGICAL MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
UNKNOWN
MDR Report Key8768481
MDR Text Key150668977
Report NumberMW5087932
Device Sequence Number1
Product Code FTL
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 07/01/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/05/2019 Patient Sequence Number: 1
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