MAUDE Adverse Event Report: CONVATEC LIMITED EAKIN COHESIVE SEALS, SMALL 2", (48MM); PROTECTOR, OSTOMY

Model Number 839002

Device Problem Material Discolored (1170)

Patient Problems Erythema (1840); Pain (1994); Fungal Infection (2419)

Event Date 01/01/2014

Event Type  Injury  

Event Description

The end user reported that she had a three month history of skin redness, 5mm in width, that is painful.In (b)(6) 2014, she saw her physician who, diagnosis as yeast infection.Prescribed kenalog spray and (b)(4) powder with each pouch change every three days.She also reported that the (b)(4) turns white and appears to take on urine.Discussed use of convexity for improved seal.Discussed crusting technique.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Third party manufacturer: (b)(4).

• Brand Name: EAKIN COHESIVE SEALS, SMALL 2", (48MM)
• Type of Device: PROTECTOR, OSTOMY
• Manufacturer (Section D): CONVATEC LIMITED; first avenue; deeside industrial park deeside; flintshire CH5 2NU; UK CH5 2NU
• Manufacturer Contact: matthew walenciak, assoc director ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4360299
• MDR Text Key: 21244122
• Report Number: 1000317571-2014-00117
• Device Sequence Number: 1
• Product Code: EXE
• 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: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 839002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2014
• 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: 73 YR
• Patient Weight: 54