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

Catalog Number BRD700SI

Device Problem Insufficient Information (3190)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Qty (b)(4)- ajust helical single incision sling (single).Qty (b)(4)- ajust" adjustable single incision sling.Qty (b)(4)- ajust" adjustable single incision sling (5-pack).Qty (b)(4)- ajust" adjustable single incision sling (single).Qty (b)(4)- unknown bmd womens health mesh product.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 Description

(b)(6).

Manufacturer Narrative

(b)(4).Original reporting time frame (b)(6) 2016 through (b)(6) 2017.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 november 1, 2016 through janurary 31, 2017.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame (b)(6) 2016 through (b)(6) 2017.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame (b)(6) 2016 through (b)(6) 2017.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame november 1, 2016 through january 31, 2017.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame november 1, 2016 through january 31, 2017.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame november 1, 2016 through january 31, 2017.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame november 1, 2016 through january 31, 2017.

Manufacturer Narrative

Exemption e2013025.Original reporting time frame november 1, 2016 through january 31, 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
• 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: 6335223
• MDR Text Key: 67581778
• Report Number: 1018233-2017-00461
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092607
• 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: 01/11/2019

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
• Device Operator: No Information
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: BRD700SI
• Device Lot Number: HUVB0915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2016
• Initial Date FDA Received: 02/16/2017
• Supplement Dates Manufacturer Received: Not provided; 12/28/2016; 12/28/2016; 12/28/2016; 12/28/2016; 12/28/2016; 12/28/2016; 12/28/2016; 12/28/2016
• Supplement Dates FDA Received: 05/23/2017; 08/30/2017; 09/22/2017; 11/20/2017; 01/22/2018; 02/22/2018; 07/30/2018; 11/15/2018; 01/11/2019
• 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