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

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).

• Brand Name: IMPLANTABLE SURGICAL MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8768481
• MDR Text Key: 150668977
• Report Number: MW5087932
• Device Sequence Number: 1
• Product Code: FTL
• 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: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 61 YR
• Patient Weight: 86