MAUDE Adverse Event Report: CONVATEC, INC. ILEODRESS DRAINABLE POUCH; URINARY, ILEOSTOMY

Model Number S413

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

Patient Problem Reaction (2414)

Event Date 07/08/2014

Event Type  Injury  

Event Description

An end user reported they had an allergic reaction to the adhesive.The end user also stated she has had bubbling of the skin under the whole area where the adhesive was in contact with the skin.The end user further stated she has been using this product for years and has not had this issue before.

Manufacturer Narrative

Based on the available information this event is deemed a serious injury.The end user stated they saw a dermatologist, who prescribed an unknown medication and was advised to change to a different product.The end user was also referred to special care nurse to advise on other products.Additional attempts were made to gather further information on 07/09/2014 and 07/10/2014; however, no additional patient / event information could be obtained regarding the complaint at this time.No additional patient / 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.

• Brand Name: ILEODRESS DRAINABLE POUCH
• Type of Device: URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 18.2; parque industrial itabo, s.a.; san cristobal, haina ; DR
• Manufacturer Contact: matthew walenciak, int.assoc.dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4020528
• MDR Text Key: 4694400
• Report Number: 9618003-2014-00069
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: S413
• Device Catalogue Number: S413
• Device Lot Number: CNO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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