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	Micturition Urgency (1871); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Pain (1994); Hernia (2240); Prolapse (2475); Constipation (3274); Urinary Incontinence (4572)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Adverse events: complications associated with the proper implantation of the align® urethral support system may include, but are not limited to: "postoperative hematoma, which may occur following the implant procedure, temporary urinary retention, bladder outlet obstruction, voiding difficulties associated with over-correction/too much tension placed on the mesh sling implant, perforations or lacerations of vessels, nerves, bladder or any viscera, which may occur during introducer needle passage, transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection and erosion of the implant.".
Event or Problem Description
It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced pain, suffering, disability and impairment.
Additional Manufacturer Narrative
2475, 1914, 1908, 2240, 3274, 1928, 1871, 2371 = "nl".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.
Event or Problem Description
Per additional information received via medical records on 30mar2022, the patient has experienced pain, chronic pelvic pain, urinary problems, urgency and painful urination, mesh migration, stress urinary incontinence, chronic constipation, hernias, hypertension, hypotension, vaginal pain, infections, uterine prolapse, vaginal vault prolapse, obstructive voiding and required additional surgical and non-surgical interventions.

• 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: 12272124
• Report Number: 1018233-2021-80056
• Device Sequence Number: 5403088
• Product Code: OTN
• UDI-Device Identifier: 00801741016189
• UDI-Public: (01)00801741016189
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K093747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 05/31/2015
• Device Model Number: BRD200S
• Device Catalogue Number: BRD200S
• Device Lot Number: HUXD1298
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 50 KG