MAUDE Adverse Event Report: C. R. BARD, INC. ALIGN; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINAR

Catalog Number BRD100R

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2013

Event Type  malfunction  

Event Description

Surgeon stated "it broke".A new kit was placed.There was no patient harm.

• Brand Name: ALIGN
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINAR
• Manufacturer (Section D): C. R. BARD, INC.; 605 n 5600 w; salt lake city UT 84116
• MDR Report Key: 3804361
• MDR Text Key: 15107313
• Report Number: 3804361
• Device Sequence Number: 1
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/07/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: BRD100R
• Device Lot Number: HUWC0341
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2014
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 79