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

Catalog Number 3223

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

Patient Problem Skin Irritation (2076)

Event Date 01/01/2016

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 recurring yeast infections cannot be determined.

Event Description

It was reported that an end user has been experiencing recurring yeast infections around her ileostomy stoma since 2016.She says she gets the infections when she swims or sweats.She has a standing order for nystatin powder which she uses with stoma powder and it clears it up.She has been put in touch with hollister customer service to see if there is a product that better meets her needs.

• 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: 10333346
• MDR Text Key: 200636484
• Report Number: 1119193-2020-00018
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 3223
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2020
• 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: 43 YR
• Patient Weight: 74