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

Catalog Number	0117310
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a product set up on (b)(6) 2022, the bard/davol 3dmax light mesh was noted to be torn when opened from the package.It was reported that there was no damage noticed on inner pouch and outer package.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the bard/davol 3dmax light mesh was found torn when opened from the package.The subject device is available for evaluation, however, at this time has not been received.Based on the information provided, no conclusion can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.If/when the sample is returned and evaluated, a supplemental mdr will be submitted.Not returned.
Additional Manufacturer Narrative
As reported, the bard/davol 3dmax light mesh was found torn when opened from the package.The subject device is available for evaluation, however, at this time has not been received.Based on the information provided, no conclusion can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document sample evaluation results.Evaluation of the sample finds that there are multiple frays/tearing in the edge seal of the mesh, and visible blood contamination on the device which indicates physical handling of the mesh during attempted use.The found edge seal and mesh tearing condition is not indicative of the as manufactured condition.No manufacturing anomalies were found.Based on the sample evaluation and investigation performed, the root cause is most likely the result of handling and inadvertently occurred during user/device interface during attempted use of the mesh.Review of manufacturing records confirms 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 october, 2021.Updated fields: b4, b5, d4 (medical device lot # and medical device expiration date), d9, g3, g6, h2, h3, h4 (device manufacture date), h6, h10.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, during a product set up on 15-mar-2022, the bard/davol 3dmax light mesh was noted to be torn when opened from the package.It was reported that there was no damage noticed on inner pouch and outer package.There was no reported patient injury.Addendum: per additional information provided, the torn mesh was noted during set up.

• Brand Name: 3DMAX LIGHT
• 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: 14014010
• Report Number: 1213643-2022-00132
• Device Sequence Number: 14609778
• Product Code: FTL
• UDI-Device Identifier: 00801741031021
• UDI-Public: (01)00801741031021
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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: 08/28/2026
• Device Catalogue Number: 0117310
• Device Lot Number: HUFW1357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 04/08/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2021
• 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: Male