MAUDE Adverse Event Report: HOLLISTER INCORPORATED PREMIER ONE PIECE HIGH OUPUT DRAINABLE POUCH; OSTOMY POUCH

Model Number 80070

Device Problems Loss of or Failure to Bond (1068); Fluid/Blood Leak (1250)

Patient Problems Skin Irritation (2076); Discomfort (2330); Skin Inflammation (2443)

Event Date 12/10/2013

Event Type  Injury  

Event Description

The following information was reported.(b)(6) year patient with an ostomy has been using the premier one piece high output drainable pouch for approximately 7 months.The last two pouches leaked against the patient's skin after 2-24 hours wear time causing irritation and open blisters around the stoma.Due to discomfort and difficulty keeping the pouch adhered the patient went to the emergency room where she was diagnosed as having contact dermatitis.She was instructed to use a cavalon durable skin barrier creme on affected areas.Patient was also put in a two piece convatec pouch and sent home.

• Brand Name: PREMIER ONE PIECE HIGH OUPUT DRAINABLE POUCH
• Type of Device: OSTOMY POUCH
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville IL 60048 378
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft 24477
• Manufacturer Contact: jennifer mason ; 2000 hollister incorporated; libertyville, IL 60048-3781 ; 8476802813
• MDR Report Key: 3567460
• MDR Text Key: 19556789
• Report Number: 1119193-2014-00003
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 80070
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2013
• Initial Date FDA Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56
• Patient Weight: 41