MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALIGN TO URETHRAL SUPPORT SYSTEM - HOOK + HALO; ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK + HALO

Model Number	BRD600HH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Frequency / Polyuria (2275); Weight Changes (2607); Foreign Body In Patient (2687); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample received.
Event or Problem Description
The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Per additional information received, the patient has experienced morbid obesity, 80 pound weight gain over one year, bilateral leg swelling/edema, leg pain (joint pain), calf tenderness, mesh noted on side of urethra/protruding into vagina (foreign body in patient), chronic pain, frequent night time urination, and required additional non surgical interventions.Per additional information received on 16oct2021, the patient has experienced mental anguish, physical pain, disfigurement and physical impairment.

• Brand Name: ALIGN TO URETHRAL SUPPORT SYSTEM - HOOK + HALO
• Common Device Name: ALIGN® TO URETHRAL SUPPORT SYSTEM - HOOK + HALO
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12669622
• Report Number: 1018233-2021-80071
• Device Sequence Number: 19209208
• Product Code: OTN
• UDI-Device Identifier: 00801741016233
• UDI-Public: (01)00801741016233
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K093747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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: 02/28/2011
• Device Model Number: BRD600HH
• Device Catalogue Number: BRD600HH
• Device Lot Number: HUTA1632
• Was Device Available for Evaluation?: No
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2021
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR