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

Catalog Number	0112660
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Impaired Healing (2378); Prolapse (2475)
Date of Event	09/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of flat mesh, patient developed pain, bleeding and the mesh breaking through the skin.Based on the information provided, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification.Note, the date of event ((b)(6) 2009) is considered as the best estimate based upon the date of implant and allegation of post-surgical complications.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 - remains implanted.
Event or Problem Description
Fda reported to rti biologics that a patient who was treated with two rti allomax grafts and a bard/davol mesh (consumer reported event (b)(4)).As reported, ¿mesh was used to repair hernia in 2009¿.¿the complainant states she has pain and bleeding¿.¿she says the mesh is breaking through her skin¿.Information reported to rti was forwarded to bd.Contact with the agency confirmed that consumer contact information cannot be provided.As such this is all of the known information.
Additional Manufacturer Narrative
As reported, post implant of flat mesh, patient developed pain, bleeding and the mesh breaking through the skin.Based on the information provided, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification.Addendum: this supplemental mdr is submitted to report the additional information and to correct the date of event.Based on the information provided, no conclusion can be made as to the degree to which the bard flat mesh, may bwe causing or contributing the patient¿s reported symptoms.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in aug, 2008.The adverse reaction section of the instructions-for-use, supplied with the device, identifies extrusion and pain as possible complications.Updated fields: a4, b4, b5, g2, g3, g6, h2, h6, h10, h11 correct field: b3 (date of event).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
Fda reported to rti biologics that a patient who was treated with two rti allomax grafts and a bard/davol mesh (consumer reported eventcc 181431).As reported, ¿mesh was used to repair hernia in 2009¿.¿the complainant states she has pain and bleeding¿.¿she says the mesh is breaking through her skin¿.Information reported to rti was forwarded to bd.Contact with the agency confirmed that consumer contact information cannot be provided.As such this is all of the known information.Addendum per additional information received through medwatch report #mw5154314: "a patient called to report the adverse events she has been experiencing from mesh implant and allomax graft she had in 2009.She stated a couple of weeks ago, she was rushed to the emergency room from vomiting and abdominal pain.Blood work showed that she was about to lose her kidney function.She said the doctor had to rush her to the operating room to remove the mesh.She said the surgeon had to cut her up all the way to her vagina.She said the wound still has not healed.She said she is still in pain from the procedure.She said her bowel hurts so bad.She said she had 2 bowel prolapses after the mesh implant and allomax graft.She said she has a son with disability.She said every time she has a procedure or rushed to the hospital, she must arrange with someone to take care of her disabled son.".
Event or Problem Description
Fda reported to rti biologics that a patient who was treated with two rti allomax grafts and a bard/davol mesh (consumer reported event (b)(6)).As reported, ¿mesh was used to repair hernia in 2009¿.¿the complainant states she has pain and bleeding¿.¿she says the mesh is breaking through her skin¿.Information reported to rti was forwarded to bd.Contact with the agency confirmed that consumer contact information cannot be provided.As such this is all of the known information.Addendum per additional information received through medwatch report #mw5154314: "a patient called to report the adverse events she has been experiencing from mesh implant and allomax graft she had in 2009.She stated a couple of weeks ago, she was rushed to the emergency room from vomiting and abdominal pain.Blood work showed that she was about to lose her kidney function.She said the doctor had to rush her to the operating room to remove the mesh.She said the surgeon had to cut her up all the way to her vagina.She said the wound still has not healed.She said she is still in pain from the procedure.She said her bowel hurts so bad.She said she had 2 bowel prolapses after the mesh implant and allomax graft.She said she has a son with disability.She said every time she has a procedure or rushed to the hospital, she must arrange with someone to take care of her disabled son." addendum per additional information provided: as reported, from (b)(6) 2009 until (b)(6) 2024 the patient has seen several physicians for various adverse reactions.Multiple x-rays were taken, and mris were performed but no surgical procedures took place.Reportedly, the patient¿s ¿wounds never healed, and she has endured extreme pain and suffering.¿ over the past 14 years, it is reported that the patient was never told that the mesh was defective and was the cause of all her problems until (b)(6) 2024 when she had to undergo an emergency surgery to remove the mesh and reconstruct her bowels and vagina as they had collapsed.¿ on (b)(6) 2024, the patient underwent an x-ray for a recently developed bulge on her right side.".
Additional Manufacturer Narrative
As reported, post implant of flat mesh, patient developed pain, bleeding and the mesh breaking through the skin.Based on the information provided, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification.Addendum #1: this supplemental mdr is submitted to report the additional information and to correct the date of event.Based on the information provided, no conclusion can be made as to the degree to which the bard flat mesh, may be causing or contributing the patient¿s reported symptoms.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2008.The adverse reaction section of the instructions-for-use, supplied with the device, identifies extrusion and pain as possible complications.Addendum #2: this supplemental mdr is submitted to report the additional information provided.Based on the information provided, no conclusion can be made as to the degree to which the bard flat mesh, may be causing or contributing the patient¿s reported symptoms.Our records continue to show this is the only reported complaint for this lot.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 FLAT 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: 17282823
• Report Number: 1213643-2023-00255
• Device Sequence Number: 5296827
• Product Code: FTL
• UDI-Device Identifier: 00801741016516
• UDI-Public: (01)00801741016516(17)130828(10)HUSG1341
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024

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 Expiration Date: 08/28/2013
• Device Catalogue Number: 0112660
• Device Lot Number: HUSG1341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 05/13/2024; 08/29/2024
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 05/23/2024; 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2008
• 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
• Patient Sex: Female
• Patient Weight: 50 KG