MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM - HALO; ALIGNTM TO URETHRAL SUPPORT SYSTEM

Model Number	BRD500HL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Discomfort (2330)
Date of Event	03/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the patient had constant discomfort and continual urinary tract infections which was treated with antibiotics at least once every three months.It was also reported that there was neurological occurrence and there was a possibility that the toxins had created from implant.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample returned for evaluation.It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be due to physician technique.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿adverse events complications associated with the proper implantation of the align® to 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 over-correction/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.¿ 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
It was reported that the patient had constant discomfort and continual urinary tract infections which was treated with antibiotics at least once every three months.It was also stated that there was a neurological occurrence and a possibility that the toxins had created from implant.

• Brand Name: ALIGN TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM - HALO
• Common Device Name: ALIGNTM TO URETHRAL SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12188468
• Report Number: 1018233-2021-04305
• Device Sequence Number: 2885508
• Product Code: OTN
• UDI-Device Identifier: 00801741016226
• UDI-Public: (01)00801741016226
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093747
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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: 10/30/2012
• Device Model Number: BRD500HL
• Device Catalogue Number: BRD500HL
• Device Lot Number: HUUJ1346
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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