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

Catalog Number	0112670
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Incontinence (1928); Pain (1994); Urinary Tract Infection (2120)
Date of Event	06/29/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
As alleged on (b)(6) 2015, the patient underwent a tot (transobturator tape) procedure for treatment of urge incontinence and was implanted with mesh.As reported on (b)(6) 2015, the patient experienced uti, urge incontinence and returned to hospital during which the patient was put on antibiotics.It was reported that over the next few years the patient had back pain, recurring uti's, pain on the right side, painful sex, autoimmune issues including vitiligo, lichen sclerosis, diverticulitis and urge incontinence.Reportedly the patient had pre-op on (b)(6) 2024 and has been waiting for a date for removal of the tot mesh.Note: the information provided by the contact lists lot numbers for two devices an adjustable single-incision sling used to treat stress urinary incontinence and a bard flat mesh.
Additional Manufacturer Narrative
As alleged, post mesh implant the patient experienced some postoperative adverse events including urinary tract infection, urge incontinence, pain, and autoimmune disease.Based on the limited information provided, no conclusion can be made as to the degree to which the bard/bd device, may be causing or contributing the patient's clinical course.Review of manufacturing records shows product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in august 2014.Note: the information provided lists lot numbers for two different devices an adjustable single-incision sling and a bard flat mesh.It is unclear if the bard flat mesh was used in some way during the tot procedure.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 alleged on (b)(6) 2015, the patient underwent a tot (transobturator tape) procedure for treatment of urge incontinence and was implanted with mesh.As reported on (b)(6) 2015, the patient experienced uti, urge incontinence and returned to hospital during which the patient was put on antibiotics.It was reported that over the next few years the patient had back pain, recurring uti's, pain on the right side, painful sex, autoimmune issues including vitiligo, lichen sclerosis, diverticulitis and urge incontinence.Reportedly the patient had pre-op on (b)(6) 2024 and has been waiting for a date for removal of the tot mesh.Note: the information provided by the contact lists lot numbers for two devices an adjustable single-incision sling used to treat stress urinary incontinence and a bard flat mesh.
Additional Manufacturer Narrative
As alleged, post mesh implant the patient experienced some postoperative adverse events including urinary tract infection, urge incontinence, pain, and autoimmune disease.Based on the limited information provided, no conclusion can be made as to the degree to which the bard/bd device, may be causing or contributing the patient's clinical course.Review of manufacturing records shows product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in august 2014.Note: the information provided lists lot numbers for two different devices an adjustable single-incision sling and a bard flat mesh.It is unclear if the bard flat mesh was used in some way during the tot procedure.Addendum: h11: this supplemental mdr is submitted to correct the labeled for single use field.Updated fields.Corrected field: h5 (labeled for single use).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: 20345197
• Report Number: 1213643-2024-00470
• Device Sequence Number: 15423801
• Product Code: FTL
• UDI-Device Identifier: 00801741016523
• UDI-Public: (01)00801741016523(17)190828(10)HUYG2042
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: 08/28/2019
• Device Catalogue Number: 0112670
• Device Lot Number: HUYG2042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2014
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 157 KG