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

Catalog Number 0117009

Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contact reports that the sample was discarded and there were no photos available to provide.As such we are unable to make a determination regarding the reported condition of the product package.Additionally, without having the lot number provided, we could not review the manufacturing records.Based on the information provided and not having a sample for review, no conclusion can be made.A review of our complaints database for a 24-month period of review, shows this to be the only reported complaint for an alleged unsealed package for soft mesh product codes.The warning section of instructions-for-use states "this device must be sterile before use.Please inspect the packaging to be sure it is intact and undamaged." should additional information be provided a supplemental emdr will be submitted.Not returned -sample discarded.

Event Description

It was reported that on (b)(6) 2020, prior to the usage of the soft mesh it was found that the inner pouch in direct contact with the mesh was not sealed.There was no damage to the outer shipping box and inner product carton or foil pouch prior to opening.The product was discarded and the procedure was completed using another piece of soft mesh.As reported, there was no reported patient injury.

• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 10310826
• MDR Text Key: 201904190
• Report Number: 1213643-2020-06852
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030864
• UDI-Public: (01)00801741030864
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K052155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0117009
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2020
• 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 Sequence Number: 1