MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD FLAT MESH; SURGICAL MESH

Catalog Number 0112680

Device Problem Material Disintegration (1177)

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

Event Date 05/04/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, the bard/davol flat mesh was noted to become damaged when tailoring to fit.The mesh was implanted in the patient, as such unavailable for review.Based on the available information and no sample to evaluate, no conclusion can be made.Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 1038 units released for distribution in october, 2020.Should additional information be provided, a supplemental mdr will be submitted.Not returned.

Event Description

As reported, during an open inguinal hernia repair procedure on (b)(6) 2021, the bard/davol flat mesh was noted to be heavy.When sizing, the mesh was friable and small pieces of the mesh crumbled off.As reported, the mesh was used for the procedure.There was no patient injury.

Event Description

As reported, during an open inguinal hernia repair procedure on (b)(6) 2021, the bard/davol flat mesh was noted to be heavy.When sizing, the mesh was friable and small pieces of the mesh crumbled off.As reported, the mesh was used for the procedure.There was no patient injury.

Manufacturer Narrative

As reported, the bard/davol flat mesh was noted to become damaged when tailoring to fit.The mesh was implanted in the patient, as such unavailable for review.Based on the available information and no sample to evaluate, no conclusion can be made.Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2020.H11.Addendum: this supplemental mdr is submitted to populate the date of implant field.Updated fields: b4, d.6a (date of implant), g3, g6, h2, h3, h10, h11.Corrected field: h6 (imdrf annex b code).Should additional information be provided, a supplemental mdr will be submitted.Note: section a through f - the information provided by bd 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 bd.

• Brand Name: BARD FLAT MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11970407
• MDR Text Key: 256060501
• Report Number: 1213643-2021-20146
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0112680
• Device Lot Number: HUEX0061
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other