MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX; SURGICAL MESH

Catalog Number 0115311

Device Problem Material Deformation (2976)

Patient Problem Pain (1994)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

As reported, post implant of two 3dmax mesh for left inguinal hernia repair the patient began experiencing pain.It is reported that the two mesh were placed on top of each other during the index procedure, and one of the mesh had ¿balled up.¿ both mesh were explanted during a subsequent procedure.A photo of the explanted mesh was provided.Depicted in the photo is the explanted mesh cut into multiple sections.A review of the photo provided does not help to determine a root cause for the reported patient¿s postoperative course.Based on the information available, no definitive conclusions can be made.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in december, 2019.This emdr represents the bard/davol 3dmax mesh (device #1).An additional emdr was submitted to represent the bard/davol 3dmax mesh (device #2).Should additional information be provided, a supplemental mdr will be submitted.

Event Description

The following was reported via maude event report (mw5102133): ¿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 sometimes, 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 its 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 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 ad 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 3dmax medium plus a large mesh on the 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 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 mesh surgery/mesh.Fda safety report id# (b)(4).¿ addendum for additional information provided in follow up: contact reports on 30-jun-2021 the patient underwent a procedure during which the mesh was explanted.As reported by the contact the surgery was ¿difficult¿ and a few days post explant the patient experienced a hemorrhage, and they were ¿waiting on it to absorb.¿ and ¿seems to be improving.¿.

• Brand Name: 3DMAX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 12303831
• MDR Text Key: 266027248
• Report Number: 1213643-2021-20241
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030734
• UDI-Public: (01)00801741030734
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0115311
• Device Lot Number: HUDX2009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 63 YR