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

Catalog Number UNKAA069

Device Problems Hole In Material (1293); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2016

Event Type  Malfunction  

Manufacturer Narrative

Although, requested product identifiers were not provided, therefore a review of the manufacturing records is not possible. Without having the lot number or sample returned for evaluation, at this time no definitive conclusions can be made regarding the root cause for the reported event. 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. Patient details are unobtainable due to the privacy laws in (b)(6). Device remains implanted.

Event Description

The following was reported to davol: it was reported that during a bilateral laparoscopic inguinal hernia repair using the tep technique, the surgeon was attempting to secure a bard soft mesh with a bard sorbafix fixation device, however the tack fired through the mesh, creating a hole and didn't hold it in place. The mesh was left in place and fixated with a non bard/davol fixation device. There was no patient injury reported.

• Brand Name: BARD SOFT MESH
• 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: 5614207
• MDR Text Key: 43841074
• Report Number: 1213643-2016-00175
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: CA
• PMA/PMN Number: K052155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: FOREIGN,HEALTH PROFESSIONAL

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/05/2016

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/28/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: UNKAA069
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 04/05/2016
• 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