MAUDE Adverse Event Report: DAVOL INC. 3D MAX MESH

Catalog Number 0115321

Device Problem Entrapment of Device (1212)

Patient Problem Pain (1994)

Event Date 08/09/2012

Event Type  Injury  

Event Description

As alleged in medwatch report (b)(4): "had bi-lateral hernia surgery with mesh implanted. One large piece of bard 3d mesh used to cover a femoral and inguinal hernia together on the right and another large piece used to cover two inguinal hernias on the left. Since weeks after surgery, have had tremendous pain in right pelvis to pelvic bone and down front of leg, and some burning in left pelvis. Also had surgical clips used to hold right peritoneum closed. Surgical report says "it opened during the surgery. " pt reported: she has seen multiple doctors and the cause of her pain is not known. An ultrasound was inconclusive. She describes her pain as sometimes debilitating. The drs have made no direct connection between the pain and an issue with the implants at this connection between the pain and an issue with the implants at this time. On (b)(6) 2012, the pt had exploratory surgery at which time the dr noted inflammation and scar tissue. He removed adhesions, and scar tissue. He also removed some tacks to relieve tension. No problem was noted with the mesh and it was left in place. Pt says she is still experiencing pain which is sometimes burning and sometimes stabbing pain. Pt reports that during the recent procedure, the surgeon removed the sorbafix tacks and he flattened the mesh and used suture to secure them.

Manufacturer Narrative

We have contacted the initial reporter to request add'l info. This mdr includes all pt, event and device info davol has received to date. Based on the info provided it is unk whether the device may have caused or contributed to the reported event. The pt reports pain since the time of implant and underwent exploratory surgery where tacks were removed. The 3d max mesh was then flattened and sutured into place. Currently, medical records have not been provided and the mesh remains implanted. A review of the mfg records was performed and there was no evidence of a mfg related cause for the reported event. With the currently available info, no conclusion can be drawn. See mdr 1213643-2012-00563 for info related to the sorbafix device used for fixation. See mdr 1213643-2012-00565 for info related to the second 3d max mesh implanted.

• Brand Name: 3D MAX MESH
• Manufacturer (Section D): DAVOL INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITED; lot #1, road #3, km 79.7; san geronimo industrial park; humacao PR 00791
• Manufacturer Contact: corie vasquez ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 2727505
• MDR Text Key: 2756265
• Report Number: 1213643-2012-00564
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: PATIENT
• Type of Report: Initial

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/30/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 09/28/2016
• Device Catalogue Number: 0115321
• Device LOT Number: HUVI0120
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2012
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 09/01/2011
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 08/30/2012 Patient Sequence Number: 1