MAUDE Adverse Event Report: HOLLISTER INCORPORATED KARAYA 5 DRAINABLE MINIPOUCH WITH TAPE BORDER; OSTOMY BARRIER

Model Number 3233

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Skin Irritation (2076); Tissue Damage (2104); Reaction (2414)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with is0 10993 and materials were found to be non-sensitizers.User has had her stoma for 35 years and has always used this product.The dhr review showed it was complete and accurate.No root cause could be determined at this time.

Event Description

It was reported by the user that on approximately (b)(6) 2016 she started noticing skin irritation under the tape portion of the barrier.It continued to worsen although she tried stoma powder and calamine lotion.The skin was bleeding, weeping, with red, prickly marks and 2 places had solid raised ulcerated areas.She saw her dermatologist who told her she was having a reaction and prescribed clobetasol proprionate 0.05% steroid gel.After two days of using the gel she noticed improvement in the area of irritation.She has been provided with new product and skin protectant gel for her to try.

• Brand Name: KARAYA 5 DRAINABLE MINIPOUCH WITH TAPE BORDER
• Type of Device: OSTOMY BARRIER
• Manufacturer (Section D): HOLLISTER INCORPORATED; 2000 hollister dr; libertyville IL 60048
• Manufacturer (Section G): HOLLISTER INCORPORATED; 366 draft avenue; stuarts draft VA 24477 9998
• Manufacturer Contact: anne riba ; 2000 hollister dr; libertyville, IL 60048 ; 8476805625
• MDR Report Key: 6170676
• MDR Text Key: 62267023
• Report Number: 1119193-2016-00026
• 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: Patient
• Type of Report: Initial
• Report Date: 11/15/2016,12/13/2016

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 Model Number: 3233
• Device Lot Number: 5L022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Date Report to Manufacturer: 11/15/2016
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/13/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 82