MAUDE Adverse Event Report: SCAPA TAPES NORTH AMERICA LLC KARAYA 5; KARAYA STOMA POWDER

Model Number	7905
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number not provided so dhr review not possible.Sample not returned so sample evaluation not possible.Post market surveillance data reviewed, and no adverse trends observed.The root cause of the reported skin irritation while using the karaya powder could not be identified.Causation could not be established.Only gudid di information is known for this product.Lot number and packaging not provided.
Event or Problem Description
It was reported that 6 weeks ago an end user used our karaya powder, and it caused a skin rash and irritation.It was further reported that the end user had to go to the er and was prescribed prednisone.

• Brand Name: KARAYA 5
• Common Device Name: KARAYA STOMA POWDER
• Manufacturer (Section D): SCAPA TAPES NORTH AMERICA LLC; 2565 bertelkamp lane; knoxville TN 37931
• Manufacturer (Section G): SCAPA TAPES NORTH AMERICA LLC; 2565 bertelkamp lane; knoxville TN 37931
• Manufacturer Contact: linda wisowaty ; 2000 hollister drive; libertyville. 60048-3781 ; 8479321271
• MDR Report Key: 20289965
• Report Number: 1480288-2024-00001
• Device Sequence Number: 12777259
• Product Code: EXE
• UDI-Device Identifier: 00610075079056
• UDI-Public: (01)00610075079056
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 7905
• Device Catalogue Number: 7905
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male