MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PHASIX ST HERNIA MESH; MESH, SURGICAL, POLYMERIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Foreign Body Reaction (1868); Headache (1880); Hematoma (1884); Nausea (1970); Pain (1994); Urinary Tract Infection (2120); Vertigo (2134); Weakness (2145); Arthralgia (2355); Depression (2361); Disability (2371)

Event Date 11/06/2019

Event Type  Injury  

Event Description

Patient called to report an adverse event involving her phasix hernia mesh she had implanted on (b)(6) 2019.Patient stated after implantation, she experienced chronic pain, foreign body reaction, flu-like symptoms, has become disabled, nausea, severe pain, headaches, vertigo, weakness, joint pain, developed hematoma¿s, depression, recurrent uti¿s, and is now bedridden.Patient stated she had the mesh explanted on (b)(6) 2020, but still has many complications and experienced very little relief.

• Brand Name: PHASIX ST HERNIA MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.
• MDR Report Key: 10091779
• MDR Text Key: 192634628
• Report Number: MW5094695
• 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: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• 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): Disability
• Patient Age: 39 YR