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

Catalog Number	0115610
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, upon opening the package of modified onflex mesh, damage was noted on the sealed edge.The subject device has been returned for evaluation.Initial evaluation of the sample found that the heat-sealed edge is partially torn off the mesh.The sample evaluation is on-going at this time, as such root cause determination has not been determined.When sample evaluation is completed, a supplemental emdr will be submitted.Review of manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in april, 2021.
Event or Problem Description
As reported, upon opening the package of the bard/davol modified onflex mesh on (b)(6) 2021, it was noted that the sealed edge was peeled off all around.As reported, no damage was noted to the outer or inner packaging.It was reported that the mesh was not used on the patient.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, upon opening the package of modified onflex mesh, damage was noted on the sealed edge.The subject device has been returned for evaluation.Initial evaluation of the sample found that the heat-sealed edge is partially torn off the mesh.The sample evaluation is on-going at this time, as such root cause determination has not been determined.When sample evaluation is completed, a supplemental emdr will be submitted.Review of manufacturing records shows the product was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of(b)(4) units released for distribution in april, 2021.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of sample evaluation.Evaluation of the returned sample noted the edge seal to be partially torn-off the mesh.The event was reported as an out-of-box condition.Per the investigation performed and sample evaluation, the most probable root cause appears to be related to manufacturing.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.H3 other text : sample evaluated.
Event or Problem Description
As reported, upon opening the package of the bard/davol modified onflex mesh on 15-nov-2021, it was noted that the sealed edge was peeled off all around.As reported, no damage was noted to the outer or inner packaging.It was reported that the mesh was not used on the patient.There was no reported patient injury.

• Brand Name: MODIFIED ONFLEX
• Common Device Name: 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: 12955100
• Report Number: 1213643-2021-20453
• Device Sequence Number: 4790067
• Product Code: FTL
• UDI-Device Identifier: 00801741095399
• UDI-Public: (01)00801741095399
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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 Expiration Date: 01/28/2024
• Device Catalogue Number: 0115610
• Device Lot Number: HUFP1360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown