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 Pain (1994); Injury (2348); Disability (2371)

Event Type  Injury  

Manufacturer Narrative

May 2019 quarterly report.Exemption e2013025.The total number of events for product classification code pah is 17.Qty 2- ajust adjustable single incision sling (5-pack).Qty 13- ajust adjustable single incision sling (single).Qty 2- unknown bmd women's health mesh product.Device evaluated by mfr: no sample received.

Event Description

May 2019 quarterly asr.

• 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; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8599019
• MDR Text Key: 144688722
• Report Number: 1018233-2019-02451
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 00801741168000
• UDI-Public: (01)00801741168000
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/10/2019

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: 04/01/2014
• Device Catalogue Number: BRD700SI
• Device Lot Number: HUWC0533
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 05/10/2019
• 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