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

Model Number	BRD100R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Pain (1994); Anxiety (2328); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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." (b)(4).No sample received.
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.
Event or Problem Description
As per medical records received on 03-jan2024, the patient experienced vaginal pain, cramping, diabetes, hypertension, urinary incontinence, stress urinary incontinence, acid reflux, low potassium, anxiety, and post-traumatic stress disorder, cystocele, mesh erosion, mesh protruding per vagina and required additional surgical and non-surgical treatments.
Additional Manufacturer Narrative
1994, 2371, 2193, 1908, 1928= "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.

• Brand Name: ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC
• Common Device Name: ALIGN® URETHRAL SUPPORT SYSTEM RETROPUBIC
• 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: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 12303077
• Report Number: 1018233-2021-80061
• Device Sequence Number: 11700240
• Product Code: OTN
• UDI-Device Identifier: 00801741016172
• UDI-Public: (01)00801741016172
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K093747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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: 05/30/2013
• Device Model Number: BRD100R
• Device Catalogue Number: BRD100R
• Device Lot Number: HUVD0850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2011
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 77 KG