MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX INGUINAL HERNIA MESH MESH, SURGICAL, POLYMERIC

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Nerve Damage (1979); Pain (1994)

Event Date 09/01/2019

Event Type  Injury  

Event Description

I have chronic pain from nerve damage from 3dmax inguinal hernia mesh. I have testicles and spermicidal cord pain too. Fda safety report id# (b)(4).

• Brand Name: 3DMAX INGUINAL HERNIA MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.
• MDR Report Key: 12843885
• MDR Text Key: 281958048
• Report Number: MW5105462
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Patient Treatment Data

Date Received: 11/18/2021 Patient Sequence Number: 1