MAUDE Adverse Event Report: CONVATEC, INC. ESTEEM & DRAINABLE OUCH EXTENDED WEAR, (64MM; POUCH, COLOSTOMY

Model Number 416976

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

Patient Problems Erythema (1840); Pain (1994); Rash (2033); Wheal(s) (2241)

Event Date 11/15/2014

Event Type  Injury  

Event Description

The end user reported she developed a red, painful, blistering rash under the device.She has applied an over the counter triple antibiotic ointment.In addition, she applied sulfadiazine and clotrimazide, previously prescribed to treat a prior unrelated condition (rash).(b)(6).

Manufacturer Narrative

Based on the available info, this event is deemed to be a serious injury.No additional pt/event details have been provided to date.Should additional info become available a follow-up report will be submitted.A return sample for evaluation is not expected.

• Brand Name: ESTEEM & DRAINABLE OUCH EXTENDED WEAR, (64MM
• Type of Device: POUCH, COLOSTOMY
• Manufacturer (Section D): CONVATEC, INC.; carretera sanchez, km. 1.5; parque industrial itabo, s.a.; haina, san cristobal 3 ; DR 3
• Manufacturer Contact: matthew walenciak ; 211 american avenue; interim associate director; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4346679
• MDR Text Key: 22062601
• Report Number: 9618003-2014-00112
• Device Sequence Number: 1
• Product Code: EZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 416976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2014
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 54