MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD BARD INLAY LUBRICIOUS COATED DOUBLE PIGTAIL URETERAL STENT

Catalog Number 778426

Device Problem Difficult to Remove (1528)

Patient Problems Calcium Deposits/Calcification (1758); Injury (2348)

Event Date 08/07/2014

Event Type  Injury  

Event Description

It was reported that the patient had a ureteral stent placed on (b)(6).After two weeks, doctors could not take out the ureteral stent and had to perform lithotripsy to remove the ureteral stent.Then they found that the stent was covered with stones include the pigtail.Due to this calcification the customer is reporting injury during removal.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

• Brand Name: BARD INLAY LUBRICIOUS COATED DOUBLE PIGTAIL URETERAL STENT
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTS PARA EL CUIDADO DE LA SALUD; km. 7 carretera internacional; nogales, sonora 8562 1; MX 85621
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4144068
• MDR Text Key: 16306061
• Report Number: 1018233-2014-00266
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2014

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: Health Professional
• Device Catalogue Number: 778426
• Device Lot Number: NGWE1394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2014
• Initial Date FDA Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 47 YR