MAUDE Adverse Event Report: HOLLISTER INCORPORATED KARAYA TAPE BORDERED DRAINABLE POUCH WITH CLAMP, 7/8" PRESIZED OPENING

Model Number 3228

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

Patient Problem Skin Irritation (2076)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Biocompatibility testing has been performed in accordance with iso 10993 and materials were found to be non-sensitizers.Lot number not provided so dhr review is not possible.Sample not returned so a sample evaluation is not possible.Trend data reviewed and no adverse trend observed.The root cause of the skin irritation under the tape and barrier cannot be determined.

Event Description

It was reported that an end user developed sores around the stoma under the hollister ostomy barrier in (b)(6) 2019 and was prescribed oral antibiotics which cleared it up.Since (b)(6), he has been having problems with sores and ulcers under the tape and barrier portion of the barrier on and off.He is under the care of a wocn who has used gauze pads with silver to apply to the deep ulcers and has now prescribed steroid powder for the contact dermatitis.

• Brand Name: KARAYA TAPE BORDERED DRAINABLE POUCH WITH CLAMP, 7/8" PRESIZED OPENING
• Type of Device: KARAYA TAPE BORDERED DRAINABLE POUCH WITH CLAMP, 7/8" PRESIZED OPENING
• 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, il ; 3602170
• MDR Report Key: 10302010
• MDR Text Key: 199680713
• Report Number: 1119193-2020-00016
• 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: Other
• Type of Report: Initial
• Report Date: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3228
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 100