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

Catalog Number 0115320

Device Problems Migration or Expulsion of Device (1395); Folded (2630); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Vomiting (2144); Obstruction/Occlusion (2422)

Event Date 06/20/2017

Event Type  Injury  

Manufacturer Narrative

As reported during a revision procedure the mesh was found to have folded over, at this time we are unable to determine to what extent, if any, the 3dmax mesh may have caused or contributed to this condition.Based on the information provided, no conclusion can be made.Note, the date of event (revision procedure) and date of implant are estimated as the contact was unable to provide exact dates.To date this is the only reported complaint for this manufacturing lot of 356 units released for distribution in (b)(6) 2015.A review of the manufacturing records was performed and found that the lot was manufactured to specification should additional information be provided, a supplemental emdr will be submitted.Note: the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Remains implanted.

Event Description

It was reported that in 2017 the patient underwent a right inguinal hernia repair with implant of a right 3dmax mesh using unknown fixation.As reported, several days after implant he began to experience extreme pain, nausea, vomiting with no bowel movement.The patient underwent an abdominal/pelvic ct scan which indicated the 3dmax mesh had migrated and folded over causing a bowel obstruction.The patient underwent a procedure which included a laparoscopy converted to an open procedure.During this procedure the mesh was found to have folded over and was obstructing the small bowel.As reported 7 inches of bowel were removed during this procedure.As stated the surgeon revised the mesh and re-fixated it in placed with unknown fixation.As reported the patient continues to experience right groin pain for which he is taking ibuprofen.As alleged the pain can hamper the patient's ability to walk some days.

• 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: 7595580
• MDR Text Key: 110855757
• Report Number: 1213643-2018-01945
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030758
• UDI-Public: (01)00801741030758
• 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: Other
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Catalogue Number: 0115320
• Device Lot Number: HUZF0646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2015
• 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