MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC NATURA PCH DRN STD CLR 45MM; POUCH, COLOSTOMY

Model Number 401955

Device Problem Defective Device (2588)

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

Event Date 02/04/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received regarding this event after filing this report will be filed on a supplemental report (medwatch 3500a).

Event Description

Complainant states: rough seam edge.

• Brand Name: NATURA PCH DRN STD CLR 45MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC; 18.5 parque industrial; haina, san cristobal 33102 ; DR 33102
• Manufacturer Contact: jeanette johnson ; 211 american ave; greensboro, NC 27409 ; 3362973009
• MDR Report Key: 5150527
• MDR Text Key: 28303414
• Report Number: 9618003-2015-30431
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/24/2018
• Device Model Number: 401955
• Device Lot Number: 3D01114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1