MAUDE Adverse Event Report: CONVATEC INC. ACTIVE LIFE ONE-PIECE UROSTOMY POUCH; BAG, URINARY, ILEOSTOMY

Model Number 650831

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Unspecified Infection (1930); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

(b)(4) based on the available information, this event is deemed to be a serious injury.No lot number or product evaluation sample is available.A detailed investigation or batch review cannot be conducted.A previous non-conformance is applicable to this complaint and is closed.No corrective actions have been identified as a result of this investigation; therefore this evaluation will be closed and will be monitored through our post market product monitoring review process.No further information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Reported to the fda on february 23, 2016.(b)(4).

Event Description

End user reported peristomal skin irritation and redness.She was seen by an emergency room doctor about one month ago.Diagnostic testing was performed and was then she prescribed an antibiotic and a cream (testing and medication not specified).She was also given an antifungal powder which has since been discontinued, as she noted that her condition did not change the appearance of the redness and was therefore not thought to be an infectious process.It was further reported that the emergency room doctor referred her to a local wound care center where the doctor there advised her to discontinue cleaning with ivory soap and the use of the adhesive spray.

• Brand Name: ACTIVE LIFE ONE-PIECE UROSTOMY POUCH
• Type of Device: BAG, URINARY, ILEOSTOMY
• Manufacturer (Section D): CONVATEC INC.; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5454490
• MDR Text Key: 38816581
• Report Number: 1049092-2016-52793
• Device Sequence Number: 1
• Product Code: EXH
• 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: Patient
• Type of Report: Initial
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 650831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2016
• 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
• Treatment: SKIN BARRIER WIPE (NAME UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 110