MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AJUST® ADJUSTABLE SINGLE-INCISION SLING

Catalog Number BRD700SI

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

Patient Problems Urinary Retention (2119); Urinary Tract Infection (2120); Prolapse (2475)

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2017 bimonthly asr report.(b)(4).The total number of events for product classification code pah is 10.Qty 5- ajust adjustable single incision sling (5-pack) qty 5- ajust adjustable single incision sling (single) 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)(6) 2017 bimonthly asr report.

Manufacturer Narrative

May 2017 bimonthly asr report.Exemption e2013025.Original reporting timeframe: march 1, 2017 through april 30, 2017.

Manufacturer Narrative

May 2017 bimonthly asr report.Exemption e2013025.Original reporting timeframe: march 1, 2017 through april 30, 2017.

• Brand Name: AJUST® ADJUSTABLE SINGLE-INCISION SLING
• Type of Device: AJUST® ADJUSTABLE SINGLE-INCISION SLING
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot #1, road #3, km 79.7; covington GA 30014
• MDR Report Key: 6559908
• MDR Text Key: 74948212
• Report Number: 1018233-2017-02367
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K092607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2018

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
• Device Operator: No Information
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: BRD700SI
• Device Lot Number: HUUL0699
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 05/11/2017
• Supplement Dates Manufacturer Received: 02/23/2017; 02/23/2017
• Supplement Dates FDA Received: 11/20/2017; 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention