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

Catalog Number	0117009
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930); Hernia (2240); Impaired Healing (2378)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient experienced infection, hernia recurrence, hematoma, and impaired healing and underwent an additional surgery to remove the hernia post implant of a soft mesh.The patient is currently awaiting an appointment with a specialist to discuss mesh removal.The information provided does not indicate a cause of the patient¿s post operative course.Based on the information provided, no conclusion can be made as to the degree to which the implant, may have caused or contributed to the patient¿s reported symptoms.Review of manufacturing records shows the 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 may 2023.The instructions-for-use supplied with the device lists hematoma, infection, and hernia recurrence as possible complications.Regarding infection, the warnings section states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device.¿ h11.This supplemental mdr is submitted to correct the imdrf annex e, f and b codes.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.
Event or Problem Description
As reported, post implant of soft mesh, the patient had multiple infections, hematoma and wound that would not heal.It is reported that the hernia was ¿outside the body now.¿ the patient was in and out of the hospital and wound care daily¿ and was treated with multiple antibiotics.It was reported that the patient underwent hernia removal surgery on (b)(6) 2024.The patient has been referred to a specialist to remove the mesh as the implanting surgeon said, ¿she cannot remove the mesh without injuring his abdominal wall.¿ reportedly, the patient is awaiting an appointment with the specialist to discuss mesh removal.
Event or Problem Description
As reported, post implant of soft mesh, the patient had multiple infections, hematoma and wound that would not heal.It is reported that the hernia was ¿outside the body now.¿ the patient was in and out of the hospital and wound care daily¿ and was treated with multiple antibiotics.It was reported that the patient underwent hernia removal surgery on (b)(6) 2024.The patient has been referred to a specialist to remove the mesh as the implanting surgeon said, ¿she cannot remove the mesh without injuring his abdominal wall.¿ reportedly, the patient is awaiting an appointment with the specialist to discuss mesh removal.
Additional Manufacturer Narrative
As reported, the patient experienced infection, hernia recurrence, hematoma, and impaired healing and underwent an additional surgery to remove the hernia post implant of a soft mesh.The patient is currently awaiting an appointment with a specialist to discuss mesh removal.The information provided does not indicate a cause of the patient¿s post operative course.Based on the information provided, no conclusion can be made as to the degree to which the implant, may have caused or contributed to the patient¿s reported symptoms.Review of manufacturing records shows the 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 may 2023.The instructions-for-use supplied with the device lists hematoma, infection, and hernia recurrence as possible complications.Regarding infection, the warnings section states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device.¿ 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 SOFT MESH
• 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: 19479943
• Report Number: 1213643-2024-00291
• Device Sequence Number: 15186553
• Product Code: FTL
• UDI-Device Identifier: 00801741030864
• UDI-Public: (01)00801741030864
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 0117009
• Device Lot Number: HUHQ1748
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Male