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

Catalog Number BRD500HL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Injury (2348); Hematuria (2558)

Event Type  Injury  

Manufacturer Narrative

(b)(4) 2016 bimonthly asr report.(b)(4).The total number of events for product classification code otn is (b)(4).Qty 22- align r retropubic urethral support system.Qty 4- align rs retropubic/suprapubic urethral support system.Qty 1- align¿ rs retropubic/suprapubic urethral support system, w/o dilator.Qty 17- align s suprapubic urethral support system.Qty 21- align to trans-obturator urethral support system- halo.Qty 19- align to trans-obturator urethral support system- hook.Qty 8- align to trans-obturator urethral support system- hook & halo.Qty 4- align urethral support system.The information provided by bard 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 bard.Sample not returned.

Event Description

(b)(4) 2016 bimonthly asr report.

Manufacturer Narrative

(b)(4).Original reporting time frame september 1, 2016 through october 31, 2016.The information provided by bard 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 bard.

Manufacturer Narrative

(b)(4).Original reporting time frame september 1, 2016 through october 31, 2016.The information provided by bard 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 bard.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Exemption e2013025.Original reporting time frame september 1, 2016 through october 31, 2016.The information provided by bard 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 bard.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame september 1, 2016 through october 31, 2016.The information provided by bard 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 bard.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame september 1, 2016 through october 31, 2016.The information provided by bard 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 bard.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame september 1, 2016 through october 31, 2016.The information provided by bard 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 bard.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame september 1, 2016 through october 31, 2016.The information provided by bard 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 bard.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame september 1, 2016 through october 31, 2016.The information provided by bard 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 bard.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame september 1, 2016 through october 31, 2016.The information provided by bard 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 bard.

• Brand Name: ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO
• Type of Device: ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot #1, road #3, km 79.7; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot #1, road #3, km 79.7; covington GA 30014
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6078892
• MDR Text Key: 59173052
• Report Number: 1018233-2016-01550
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2011
• Device Catalogue Number: BRD500HL
• Device Lot Number: HUTB1951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention