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

Catalog Number	5959680
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during implant of an sepramesh ip, the mesh was noted to be 'fractured'.No patient impact was reported.The subject device has not been returned for evaluation.Based on the limited information provided and without having the sample to evaluate, no conclusion can be made.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 66 units released for distribution in december, 2021.Not returned.
Event or Problem Description
As reported, during an unknown procedure, when the surgeon attempted to implant the bard/davol sepramesh ip, it was noted to be 'fractured'.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, during implant of an sepramesh ip, the mesh was noted to be 'fractured'.No patient impact was reported.The subject device has not been returned for evaluation.Based on the limited information provided and without having the sample to evaluate, no conclusion can be made.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 66 units released for distribution in december, 2021.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the additional information regarding the correct event date and event details.As reported, during implant of an sepramesh ip, the mesh had a "break", another unknown mesh was used to complete the procedure.There was no reported patient injury.Based on the information provided, no conclusion can be made.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 : not returned - mesh discarded.
Event or Problem Description
As reported, during an unknown procedure, when the surgeon attempted to implant the the bard/davol sepramesh ip, it was noted to be 'fractured'.There was no reported patient injury.Addendum per additional information: as reported, during a laparoscopic procedure on (b)(4) 2022, when the surgeon attempted to implant the the bard/davol sepramesh ip, the mesh had a "break".As reported, the procedure was completed using an unknown mesh and there was delay in the procedure due to the product issue.There was no reported patient injury.

• Brand Name: SEPRAMESH IP
• 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: 15209336
• Report Number: 1213643-2022-00581
• Device Sequence Number: 2109130
• Product Code: FTL
• UDI-Device Identifier: 00801741031823
• UDI-Public: (01)00801741031823
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K063739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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: 10/28/2023
• Device Catalogue Number: 5959680
• Device Lot Number: HUFY0114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2021
• 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