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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD 3D MAX MESH MESH, SURGICAL, POLYMERIC

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DAVOL INC., SUB. C.R. BARD, INC. BARD 3D MAX MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 0115310
Device Problem Malposition of Device (2616)
Patient Problem Pain (1994)
Event Date 05/15/2020
Event Type  Injury  
Event Description
I had a life prior to my hernia surgery in 2020. Following are dates/events: on (b)(6) 2020 went to surgeon #1 (b)(6) in (b)(6). I had left inguinal hernia repair. Had a bulge for several months, but no pain. Dr. Said better to take care of early to avoid possible emergency complications if i wait. Surgeon said he would use da vinci robotic with mesh. We specifically asked about the mesh as we have seen many commercials for mesh lawsuits. Surgeon assured us what he uses is none those in lawsuits and is perfectly safe. He never mentioned there was a "no mesh" option. I followed the 6-weeks recovery regime, and was still in pain, 24/7, more stabbing when sitting, lifting leg to put on pants, bending over to pick up something, bumps while riding in a car hurt, so really didn't do much of anything for about 4 months. Pain moves around from groin to hip. On approximately (b)(6) 2020 called surgeon #1 because still in pain 24/7 and had only started back of minimal activity (longer walks, playing pickleball). He said to give it a few more months, sometimes takes up to 6 months to heal. Was in bed for 2 weeks with terrible pain. With some rest, was able to get out of bed again but not able to resume normal life. On (b)(6) 2020 went to surgeon #2 (b)(6) in (b)(6) because pain remains 24/7 and no normal life. He said he sees pain after hernia surgeries some times, and i will just have to live with it. He had no comments on the operative report i showed him. In approximately (b)(6) 2020, i called surgeon #1 and he said to wait another month, that sometimes it takes 6 months to heal. After 6 months, no improvement. On (b)(6) 2021 went back to surgeon #1. He ordered dose pack of prednisone. No improvement. He said i should not be in pain and ordered ct scan. Based on my description of pain, he said he thinks it's nerve related, so sent me to pain specialist for nerve block. On (b)(6) 2021 had ct scan done. On (b)(6) 2021 talked to surgeon #1 to let him know dose pack did not help. On (b)(6) 2021 went to pain specialist # 3 (b)(6). He thought it was also nerve related and suggested the inguinal nerve block. On (b)(6) 2021 went to surgeon # 4 (b)(6) because i wanted to get another opinion from the 3 doctors i've already seen. He wanted to numb the groin area, and then recommended a nerve block if the area he numbed seem to relieve the pain for a few hours. No relief. I asked if the 2 pieces of mesh used (a medium plus a large in same spot) was common practice and he said he's never done that before and hasn't heard of it being done. On (b)(6) 2021 went back to pain specialist #3 for nerve block. Said to come back in 2 weeks. On (b)(6) 2021 returned to pain specialist #3 to tell him the nerve block did not help and still in pain 24/7. Said i needed to go back to surgeon #1, nothing else he can help me with. On (b)(6) 2021 talked to surgeon #1 again and he said to try another dose pack of prednisone. I chose not to because it didn't help the first time and i didn't like the effects of the drug. Just being bounced around with no relief. On (b)(6) 2021 went to surgeon #5 (b)(6). He only does hernias. He looked at the ct scan, felt my groin, moved my leg around some, and said it is not nerve related, but the mesh was not put in correctly. Said surgeon #1 may be a nice guy, but he didn't place it correctly. He said the mesh needs to be removed. Operative notes showed surgeon #1 put in bard 3d max medium plus a large mesh on top of each other. This is not common practice to place 2 pieces on top of each other like that. On (b)(6) 2021 went to surgeon #6 (b)(6). He looked at the ct scan, felt my groin, moved my leg around some and also said he doesn't believe it is nerve related, but one of the mesh is balled up and all mesh needs to be removed. He said mesh should not be placed together like that. I have been completely ruined by this surgery/mesh. Fda safety report id# (b)(4).
 
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Brand NameBARD 3D MAX MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
MDR Report Key12066615
MDR Text Key258898043
Report NumberMW5102133
Device Sequence Number1
Product Code FTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/22/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0115310
Device Catalogue Number0115310
Device Lot NumberHUDX1393
Was Device Available for Evaluation? No Answer Provided
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: 06/24/2021 Patient Sequence Number: 1
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