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

Catalog Number 0117310

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

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2015

Event Type  malfunction  

Manufacturer Narrative

The evaluation is in process at this time.Upon completion of the evaluation a supplemental mdr will be sent to document the findings.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: it was reported that the edge of the mesh was torn.This was noted during inventory review.There was no patient involvement.

Manufacturer Narrative

This is an addendum to the initial mdr to report the findings of the sample evaluation.The evaluation is confirmed for torn and frayed material.The sample was received in an opened pouch and the clamshell inside the pouch does not provide a closure seal, thus unit handling by the end user while not reported, cannot be excluded.A review of the manufacturing records was performed and found that the lot was manufactured to specification with no anomalies noted.The review does not indicate that the problem was caused during the manufacture of the device.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released to production on (b)(6) 2014.Davol will continue to monitor for similar reports.

• Brand Name: 3DMAX LIGHT
• 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: 5274515
• MDR Text Key: 32937281
• Report Number: 1213643-2015-00417
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 0117310
• Device Lot Number: HUYD1640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1