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

Catalog Number 0115311

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

The returned sample has been evaluated. This was reported as an out of box condition and the returned sample did not appear to be contaminated. The evaluation finds for tears/ frays along the edge seal of the device. Also noted are two areas of torn mesh both close to the edge of the device. A review of the manufacturing records found the lot was manufactured to specification with no anomalies. Based on the event as reported, review of the manufacturing records and the sample evaluation, root cause is undetermined at this time. However, unit handling by the end user while not reported, cannot be excluded as a possible cause. 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

It was reported that a 3dmax mesh was found to be damaged out of the packaging. The device was not used in the case. There was no patient involvement.

• 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: 5936616
• MDR Text Key: 54276719
• Report Number: 1213643-2016-00426
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K081010
• 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: 08/15/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 0115311
• Device Lot Number: HUAP0685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial