MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC, INC. ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAINABLE POUCH - APS; POUCH, COLOSTOMY

Model Number 416718

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

Per the end user, the tail of the bag was welded and could not drain.No further information provided.

Manufacturer Narrative

There were no nonconformances raised for this product during the previous 12 months.There is no indication of an adverse trend over the past twelve months (jan.2012 to jan.2013) for this complaint/product.

• Brand Name: ESTEEM 1 PC - 1 PC DRAINABLE INVISICLOSE DRAINABLE POUCH - APS
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC, INC.; carretera sanchez, km. 18.5; parque industrial; san cristobal, haina 3310 2; DR 33102
• Manufacturer Contact: matthew walenciak, director post ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4132822
• MDR Text Key: 16781699
• Report Number: 9618003-2014-11332
• 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: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/28/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/09/2017
• Device Model Number: 416718
• Device Lot Number: 2B01294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• 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
• Patient Outcome(s): Other