MAUDE Adverse Event Report: HOLLISTER INCORPORATED KARAYA 5 ONE PIECE PRE-SIZED DRAINABLE OSTOMY POUCH

Catalog Number 3228

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

Patient Problem Pressure Sores (2326)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

Trend data reviewed and this was identified as an isolated incident.Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.Dhr review was not possible because lot number not provided.Sample review not possible because no sample available.The root cause of the peristomal injury could not be confirmed.

Event Description

It was reported that an end user has been using this hollister ostomy appliance for 45 years.Over the last 6 weeks, he has developed a peristomal wound located above his stoma.The wound is causing him to have to change is ostomy appliance between 1 to 5 times a day.His wocn nurse stated that the end user has gained weight, has a belly and is using the wrong product.The wocn thinks it may be a pressure sore from the appliance and has been treating him with numerous wound care products in order to help resolve the wound.Hollister is sending him samples of flat ostomy barrier appliances per the wocn's request.

• Brand Name: KARAYA 5 ONE PIECE PRE-SIZED DRAINABLE OSTOMY POUCH
• Type of Device: KARAYA 5 ONE PIECE PRE-SIZED DRAINABLE OSTOMY POUCH
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister drive; libertyville, il
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft, va
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville., ; 6802170
• MDR Report Key: 10391369
• MDR Text Key: 202517607
• Report Number: 1119193-2020-00022
• Device Sequence Number: 1
• Product Code: EXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/11/2020

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: Lay User/Patient
• Device Catalogue Number: 3228
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 69 YR
• Patient Weight: 95