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

Model Number	BRD300RS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Aug 2017 quarterly asr report exemption e2013025 the total number of events for product classification code otn is 49.Qty 10- align r retropubic urethral support system qty 5- align rs retropubic/suprapubic urethral support system qty 2- align¿ rs retropubic/suprapubic urethral support system, w/o dilator qty 7- align s suprapubic urethral support system qty 10- align to trans-obturator urethral support system- halo qty 8- align to trans-obturator urethral support system- hook qty 4- align to trans-obturator urethral support system- hook & halo qty 2- align urethral support system qty 1- unknown bmd women¿s health mesh product h11:section a through f - 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.
Event or Problem Description
August 2017 quarterly asr report.
Additional Manufacturer Narrative
Exemption e2013025.Original reporting time frame may 1, 2017 through july 31, 2017.
Additional Manufacturer Narrative
Exemption e2013025.Original reporting time frame (b)(6) 2017 through (b)(6) 2017.
Additional Manufacturer Narrative
Exemption e2013025.Original reporting time frame (b)(6) 2017 through (b)(6) 2017.
Additional Manufacturer Narrative
Exemption e2013025.Original reporting time frame (b)(6) 2017 through (b)(6) 2017.
Additional Manufacturer Narrative
Exemption: e2013025.
Additional Manufacturer Narrative
Exemption: e2013025.
Additional Manufacturer Narrative
Exemption: e2013025.
Additional Manufacturer Narrative
Exemption: e2013025.
Additional Manufacturer Narrative
Exemption: e2013025.
Additional Manufacturer Narrative
Exemption: e2013025.
Additional Manufacturer Narrative
Exemption: e2013025.
Additional Manufacturer Narrative
Exemption: e2013025.

• Brand Name: ALIGN® RS URETHRAL SUPPORT SYSTEM
• Common Device Name: ALIGN® RS URETHRAL SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6829665
• Report Number: 1018233-2017-04535
• Device Sequence Number: 16521860
• Product Code: OTN
• UDI-Device Identifier: 00801741016196
• UDI-Public: (01)00801741016196
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K070073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/15/2019

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: No Information
• Device Expiration Date: 11/30/2008
• Device Model Number: BRD300RS
• Device Catalogue Number: BRD300RS
• Device Lot Number: CVRJ0091
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 05/15/2017; 05/15/2017; 05/15/2017; 05/15/2017; 05/15/2017; 05/15/2017; 05/15/2017; 05/15/2017; 05/15/2017; 05/15/2017; 05/15/2017; 05/15/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 09/27/2017; 11/27/2017; 01/26/2018; 02/22/2018; 05/24/2018; 07/30/2018; 08/21/2018; 11/15/2018; 01/15/2019; 02/07/2019; 03/14/2019; 05/15/2019
• 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