CAM SYSTEM

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR UNIT (B)(6) CORRESPONDING TO COMPLAINT REFERENCE NUMBER (B)(4), HAS BEEN REVIEWED FOR COMPLIANCE WITH ESTABLISHED DEVICE MASTER RECORD (DMR), INCLUDING CERTIFICATES OF CONFORMANCE FOR PATIENT CONTACT MATERIALS. EXAMINATION OF DEVICE RECORDS DETERMINED NO DISCREPANCIES OR INSTANCES OF NON-CONFORMITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAM PRODUCT INSTRUCTIONS FOR USE (IFU) LISTS SKIN IRRITATION, ALLERGIC SKIN REACTIONS AND ALLERGIC SYMPTOMS AS POTENTIAL RISKS ASSOCIATED WITH DEVICE USE. THE IFU INSTRUCTS PATIENTS TO REMOVE THE CAM IMMEDIATELY AND CONTACT THEIR PHYSICIAN IF IRRITATION SUCH AS REDNESS, SEVERE ITCHING, OR ALLERGIC SYMPTOMS DEVELOP.

Description of Event or Problem

ORIGINAL COMPLAINT (FROM (B)(4) (2311)): "CAM ADHESIVE CAUSED SKIN IRRITATION IN CENTER OF CHEST WHICH SPREAD TO NECK AREA. SKIN BECAME ITCHY, RED AND BURNING. IRRITATION LEFT SCAR ON CHEST AREA. PATIENT STATED HAD TO GO TO URGENT CARE FOR TREATMENT AND WAS PRESCRIBE TRIAMCINOLONE." ADDITIONAL INFORMATION: MULTIPLE ATTEMPTS WERE MADE TO CONFIRM IF THE PRESCRIBED TRIAMCINOLONE WAS TOPICAL OR ORAL DETAILS WITHOUT SUCCESS. IT IS UNKNOWN IF THE PATIENT USED A TOPICAL OR ORAL PRESCRIPTION.