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

Catalog Number 0117009

Device Problem Material Integrity Problem (2978)

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

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

As reported, the soft mesh was noted to have ¿jagged¿ edges after the surgeon tailored the mesh, using curved mayo scissors.The sample was reported to have been implanted in the patient, as such is not available for evaluation.There has been no patient injury reported.Based on the available information, 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 (b)(4) units released for distribution in september, 2021.The instructions-for-use supplied with the mesh adequately describes the proper technique for implantation and states, "intact bard¿ soft mesh exhibits high burst and tensile strength.However, when custom tailoring, in special circumstances where excessive force is placed on the mesh, the following guidelines may be helpful: when cutting a notch in the mesh, a v-shape with a radiused point will withstand more force than a v-shape which comes to a sharp point." should additional information be provided, a supplemental mdr will be submitted.Remains implanted.

Event Description

As reported during an open inguinal hernia repair procedure on (b)(6) 2021, the bard soft mesh was cut to size with curved mayo scissors.As reported "the cross sections were sticking out poking into the tissue.This was felt as a safety concern by the physician that this ¿jagged¿ edge could potentially damage nerves in the area or the tissue." as reported, the size of the mesh after being cut is not known.It was reported that the mesh was used and remains implanted in the patient.As reported, there was no patient injury and the patient did not require any additional medical or surgical intervention.

• Brand Name: BARD SOFT MESH
• Type of Device: 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: 12970678
• MDR Text Key: 284179232
• Report Number: 1213643-2021-20459
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030864
• UDI-Public: (01)00801741030864
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0117009
• Device Lot Number: HUFV0737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 92 KG