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

Catalog Number	0117009
Medical Device Problem Codes	Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10310826
• Report Number: 1213643-2020-06852
• Device Sequence Number: 16993847
• Product Code: FTL
• UDI-Device Identifier: 00801741030864
• UDI-Public: (01)00801741030864
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0117009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1