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

Catalog Number UNKAA001

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Nerve Damage (1979); Hernia (2240); Bowel Perforation (2668)

Event Type  Injury  

Manufacturer Narrative

No conclusion can be made.It is alleged that the patient was implanted with 3 bard devices in 2014.As alleged since approximately eight (8) months post implant the patient continues to experience multiple postoperative symptoms.Although the medical records provided were limited information states constipation, diarrhea and pain were due to diverticulitis.The medical records also included an office note from the patient's md indicating a left side (device #2) recurrent hernia.As reported, there has been no surgical procedure performed to date.Recurrence is a known inherent risk of hernia repair surgery and is listed in the instructions-for-use as a possible complication.A lot number was not provided; without a lot number a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.This emdr represents device #2 additional emdrs were submitted to represent device #1 and device #3.Remains implanted.

Event Description

The following was reported to davol and is based on information provided by contact: it is alleged that on (b)(6) 2014 the patient was implanted with three bard mesh devices.As alleged a ventralex st mesh (device #1) was placed for the repair of an umbilical hernia and two 3dmax mesh (device #2 and device #3) were placed for bilateral repair in the groin area.As reported about 8 months after the implant procedure, the patient experienced abdominal pain and constipation.Due to these symptoms the patient went to the hospital where he was diagnosed with a bowel obstruction.Reportedly the patient is having significant issues with his bowels, experiences urinary retention and has been to numerous doctors over the years about his issues.The contact reports the mesh has moved in the patient's stomach which is causing all of his issues.As alleged the patient is experiencing a golf ball-like appearance in the area of the implant (device #2), pain, swelling, trouble with the digestion process, pain in the area which radiates to the neck, lower back pain, trouble going to the bathroom, nerve involvement, and impingement on the small intestine which shows ¿strings¿.As reported the patient has to eat salads or else he gets ill.The patient has consulted with a surgeon who wants more information about the mesh he had implanted before removing the mesh from the patient.The following is based on medical records provided by contact: on (b)(6) 2017 office visit patient diagnosed with constipation, diarrhea and pain due to diverticulitis.On (b)(6) 2019 office note from the patient's md indicates a left side (device #2) recurrent hernia with recommendation to have a laparoscopic repair of the hernia.As reported, there has been no surgical procedure performed to date.

• Brand Name: 3DMAX
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: laura sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 10119040
• MDR Text Key: 194018660
• Report Number: 1213643-2020-05391
• Device Sequence Number: 1
• Product Code: FTL
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 94