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

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.

• 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 berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 5878217
• MDR Text Key: 52171451
• Report Number: 1213643-2016-00382
• 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: 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 Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKAA001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 07/28/2016
• 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