MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC

Model Number	BRD200S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency / Polyuria (2275); Foreign Body In Patient (2687); Constipation (3274); Dyspareunia (4505)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: ¿complications associated with the proper implantation of the align® urethral support system may include, but are not limited to: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.Urinary retention, bladder outlet obstruction and other voiding dysfunctions.These conditions may be associated with overcorrection/ too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, or any viscera, which may occur during the implantation procedure.Irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.Extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.Inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of incontinence." 1994 = "l".2348, 2687 = "nl".
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Product was used for therapeutic treatment.Per additional information received, the patient has experienced foreign body in genitourinary tract, (foreign body in patient), palpable mesh, dyspareunia, needle stick sensation during intercourse, decreased libido, pelvic pain, nocturia, urge incontinence, (urinary frequency), (urinary retention), urinary stream abnormality/starts/stops, stress incontinence, difficulty voiding, mesh erosion, urethral obstruction, and required non-surgical and additional surgical interventions.Per additional information received via medical records on 4/23/2018, the patient has experienced mesh embedded in bladder, pain with sex, unspecified emotional problems, inability to hold urine, adhesions, constipation, pelvic trauma, urinary incontinence, nonsurgical and additional surgical interventions.Per additional information received on 12apr2021, the patient experienced mesh erosion, tissue erosion, exposed and protruding mesh, pain, bleeding, infection and dyspareunia, requiring a second surgery to remove the align.
Event or Problem Description
Per additional information received the patient has experienced urinary tract infections and required additional surgical and non-surgical interventions.
Additional Manufacturer Narrative
2120="l".H11: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: ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC
• Common Device Name: ALIGN® S URETHRAL SUPPORT SYSTEM SUPRAPUBIC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 11706000
• Report Number: 1018233-2021-80033
• Device Sequence Number: 3895044
• Product Code: OTN
• UDI-Device Identifier: 00801741016189
• UDI-Public: (01)00801741016189
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2021

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: 09/30/2012
• Device Model Number: BRD200S
• Device Catalogue Number: BRD200S
• Device Lot Number: HUUH1462
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2010
• 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: 68 KG
• Patient Race: White