MAUDE Adverse Event Report: CONVATEC INC ESTEEM 1 PC DRAINABLE INVISICLOSE DRAINABLE; POUCH, COLOSTOMY

Model Number 420343

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/17/2014

Event Type  Injury  

Event Description

It was reported an allergic reaction occurred around the ostomy of a pt.

Manufacturer Narrative

Based on the available information, this event is deemed a serious injury.It was reported treatment for the allergic reaction was given to the pt, the device was removed and a competitor product was used.Additional pt information was received, via email, on (b)(4) 2014 which stated, "the locoid lotion was prescribed by the ostomy nurse following the allergic reaction." no additional pt/event details have been provided to date.Should additional information become available a follow-up report will be submitted.A return sample for evaluation is not expected.Reported to the fda on (b)(4) 2014.

• Brand Name: ESTEEM 1 PC DRAINABLE INVISICLOSE DRAINABLE
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC INC; carretera sanchez, km 18.5; parque industrial itabo, s.a.; san cristobal 3, haina ; DR
• Manufacturer Contact: matthew walenciak, int ass dir ; 200 headquarters park drive; skillman, NJ 08558 ; 9083779293
• MDR Report Key: 3760942
• MDR Text Key: 15109375
• Report Number: 9618003-2014-00039
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/10/2018
• Device Model Number: 420343
• Device Catalogue Number: 420343
• Device Lot Number: 3K03263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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
• Patient Outcome(s): Required Intervention