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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 UNKAA001
Device Problems Break (1069); Migration or Expulsion of Device (1395)
Patient Problem Erosion (1750)
Event Date 09/25/2015
Event Type  Injury  
Manufacturer Narrative

The information on the maude event report is vague and did not include contact information for the reporter. The maude event report identifies two devices a bard 3dmax mesh and a bard xenmatrix graft. There is no implant date listed for the 3dmax mesh, there is an event date of (b)(6) 2015 and there is an implant date for the xenmatrix graft of (b)(6) 2015. It would appear that the patient's reported issues are associated to the 3dmax mesh as the event date listed is prior to the implant date of the xenmatrix graft. Therefore, this report is submitted to represent the bard 3dmax mesh device. No lot number has been provided; therefore a review of the manufacturing records could not be conducted. Based on the limited information available and having no way of contacting the reporter or the patient, at this time no conclusions can be made. If additional information is obtained, a supplemental mdr will be submitted. 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.

 
Event Description

The following was reported to davol via maude event report (mw5063263): "reporter said he had mesh implant which broke and eroded into his appendix, scrotum, belly and into his bottom. " it appears that the alleged problem was reported by a patient to a nurse who then reported this to the fda via maude database. The nurse reporting the event to the fda did not include any information that would allow for direct follow up. As such no additional information can be gathered at this time.

 
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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 berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key5878217
MDR Text Key52171451
Report Number1213643-2016-00382
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 07/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA001
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received07/28/2016
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 TREATMENT DATA
Date Received: 08/16/2016 Patient Sequence Number: 1
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