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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. 3DMAX INGUINAL HERNIA MESH MESH, SURGICAL, POLYMERIC Back to Search Results
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).
 
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Brand Name3DMAX INGUINAL HERNIA MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
MDR Report Key12843885
MDR Text Key281958048
Report NumberMW5105462
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 11/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2021
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
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