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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. 3DMAX SURGICAL MESH Back to Search Results
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.

 
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Brand Name3DMAX
Type of DeviceSURGICAL 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 Key7595580
MDR Text Key110855757
Report Number1213643-2018-01945
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
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 Received06/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/28/2020
Device Catalogue Number0115320
Device LOT NumberHUZF0646
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/09/2015
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: 06/13/2018 Patient Sequence Number: 1
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