ORTHO SKIN 2"OS2 052

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-26 for ORTHO SKIN 2"OS2 052 manufactured by Ortho Care Casting, Llc.

Event Text Entries

[24820092] Surgeon reported adverse skin reactions in 5/5 patients post operatively including skin maceration in 1/5. All patient's had applied intraop, "ortho skin" waterproof cast liner. Diagnosis or reason for use: applied intraop b surgeon during the timeframe. Event abated after use stopped or dose reduced? Yes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5055846
• MDR Report Key: 5045373
• Date Received: 2015-08-26
• Date of Report: 2015-08-26
• Date of Event: 2015-08-20
• Date Added to Maude: 2015-09-01
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: ORTHO SKIN
• Generic Name: WATERPROOF CAST LINER
• Product Code: IPM
• Date Received: 2015-08-26
• Model Number: 2"OS2
• Catalog Number: 052
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ORTHO CARE CASTING, LLC
• Manufacturer Address: RAYTOWN MO 64138 US 64138

Device Sequence Number: 2

• Brand Name: ORTHO SKIN
• Generic Name: WATERPROOF CAST LINER
• Product Code: IPM
• Date Received: 2015-08-26
• Model Number: 3"053
• Catalog Number: 053
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 2
• Device Event Key: 0

Device Sequence Number: 3

• Brand Name: ORTHO SKIN
• Generic Name: WATERPROOF CAST LINER
• Product Code: IPM
• Date Received: 2015-08-26
• Model Number: 4"054
• Catalog Number: 054
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 3
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2015-08-26