MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT SURGICAL MESH

Catalog Number 0117321

Device Problem Material Frayed (1262)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, the bard/davol 3dmax light mesh was "cracked" upon removing from the package. The event was reported as an out of box observation. The sample has not been returned for evaluation. Review of manufacturing records indicate product was manufactured to specification. Based on the information available and without having the sample to evaluate, no conclusion can be made. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in august, 2019. If/when sample is received and evaluated, a supplemental emdr will be submitted. Not returned.

Event Description

As reported, during an unknown procedure, the bard/davol 3dmax light mesh was noted to be "cracked" when removed from the product packaging. The mesh was not used and there was no reported patient injury.

• Brand Name: 3DMAX LIGHT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 12145593
• MDR Text Key: 260873882
• Report Number: 1213643-2021-20182
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 0117321
• Device Lot Number: HUDT2060
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2019
• 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: 07/09/2021 Patient Sequence Number: 1