EYE-PAK OPHTHALMIC DRAPE

Additional Manufacturer Narrative

NO PRODUCT HAS BEEN RETURNED THE INVESTIGATION SITE FOR EVALUATION; THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. IMAGES WERE PROVIDED OF THE PATIENT TO SHOW THE ALLEGED RASH ON UPPER CHEEK. THE SUPPLIER MANUFACTURER PROVIDED TECHNICAL DATA AND LITERATURE INFORMATION FOR THE MEDICAL TAPE/ADHESIVE USED FOR THE DRAPE. THIS INFORMATION WAS ALSO SHARED WITH THE SURGEON AND FACILITY. THE MEDICAL TAPE SUPPLIER CONFIRMED THE PRODUCT (ADHESIVE) WAS EXPOSED TO THE FOLLOWING TESTING AND RESULT: - EUROPEAN STANDARD INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (EN ISO) 10993-5: BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 5: TESTS FOR IN VITRO CYTOTOXICITY. - EUROPEAN STANDARD INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (EN ISO) 10993-5: CYTOTOXICITY (MEM ELUTION ASSAY). - EUROPEAN STANDARD INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (EN ISO) 10993-10: TESTS FOR IRRITATION AND DELAYED-TYPE HYPERSENSITIVITY. ALL TESTS PASSED. ALSO, THE SUPPLIER TECHNICAL DATA INFORMATION PROVIDED CONFIRMS THE ADHESIVE IS DESIGNED FOR SURGICAL AND MEDICAL USE. TWO OF THE PRIMARY FEATURE(S)/BENEFIT(S) OF THE MEDICAL TAPE IS THE HYPOALLERGENIC PRESSURE SENSITIVE ADHESIVE AND GOOD ADHESION TO SKIN CHARACTERISTICS IT EXHIBITS. THE REPORTED PRODUCT¿S LOT NUMBER WAS NOT REPORTED, PREVENTING LOT NUMBER SPECIFIC REVIEWS FOR SIMILAR COMPLAINTS OR NON-CONFORMANCES. HOWEVER, BEFORE PRODUCTION RELEASE, EACH PRODUCT HISTORY RECORD IS REVIEWED TO ENSURE THAT ALL ASSOCIATED PRODUCTS MEET THE REQUIRED SPECIFICATIONS AND RELEASE CRITERIA. THE ROOT CAUSE OF THE CUSTOMER¿S COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED; PRODUCT PROBLEM WAS UNABLE TO BE IDENTIFIED. THE MEDICAL TAPE TECHNICAL DATA AND LITERATURE PROVIDED BY THE SUPPLIER DEMONSTRATES THEY HAVE CONDUCTED TESTING IN ACCORDANCE WITH INTERNATIONAL ORGANIZATION FOR STANDARDIZATION STANDARD REGULATIONS. THEREFORE, BASED ON THE SUPPLIER TECHNICAL DATA, TESTING, RESULTS, AND LITERATURE, THE PRODUCT (MEDICAL TAPE/ADHESIVE) HAS BEEN DESIGNATED AS SAFE TO USE IN BOTH SURGICAL AND MEDICAL APPLICATIONS. THE ROOT CAUSE COULD NOT BE ESTABLISHED AND REVIEW OF THE SPECIFICATIONS OF THE ALLEGED GOWN DID NOT IDENTIFY ANY CONTRIBUTOR TO THIS REPORTED EVENT, THEREFORE, SPECIFIC ACTION WITH REGARDS TO THIS COMPLAINT CANNOT BE TAKEN. RECEIPT OF ADDITIONAL RELEVANT INFORMATION OR SUPPORTING MATERIALS WILL PROMPT A RE-EVALUATION OF THE COMPLAINT INVESTIGATION. ALL PACKS ARE DELIVERED TO OUR CUSTOMERS IN A STERILE MANNER. AN EVALUATION IS CONDUCTED TO ENSURE EACH REQUESTED ITEM MEETS CUSTOMER, PROCESS, AND REGULATORY REQUIREMENTS. COMPLAINT DATA FOR ALL PRODUCTS IS REVIEWED MONTHLY TO MONITOR FOR ADVERSE TRENDS. DURING THE LAST REVIEW, NO ADVERSE TRENDS WERE OBSERVED FOR THE REPORTED PRODUCT AND EVENT COMBINATION. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED RASH ON UPPER CHEEK THAT ASSOCIATED WITH DRAPE ADHESIVE AFTER SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PATIENT UNDERWENT CARE FROM A DERMATOLOGIST. THE CURRENT PATIENT CONDITION WAS IMPROVING.

Additional Manufacturer Narrative

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).