DERMABOND PRINEO

Description of Event or Problem

IT WAS REPORTED A PATIENT UNDERWENT A KNEE REPLACEMENT ON AN UNKNOWN DATE AN TOPICAL SKIN ADHESIVE WAS USED. ONE CASE INVOLVED A TOTAL JOINT REPLACEMENT HOWEVER, DESCRIBED AS SHOWING RAISED, BLISTER-LIKE, AND VERY RED SKIN REACTIONS. THIS CASE OCCURRED APPROXIMATELY ONE WEEK POST-OPERATIVELY FOLLOWING A TOTAL KNEE REPLACEMENT PROCEDURE. THE PATIENT EXPERIENCED A REACTION BUT INITIALLY ELECTED TO RETAIN THE IMPLANT. THE PATIENT SUBSEQUENTLY REQUIRED TWO SEPARATE WOUND DEBRIDEMENT PROCEDURES TO CLEAN THE AFFECTED AREA HOWEVER, THE JOINT REPLACEMENT REMAINED INTACT AND WAS NOT REVISED. THE PATIENT WAS REPORTED TO BE DOING FINE AT THE TIME OF REPORTING. NO ADDITIONAL PATIENT OUTCOME DETAILS WERE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT#: (B)(4). ADDITIONAL INFORMATION: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. ADDITIONAL INFORMATION PROVIDED: ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. IS PHOTO AVAILABLE OF PATIENT REACTION? DESCRIPTION OF EVENT, SYMPTOMS, MANIFESTATION OF REACTION. WHAT WAS THE PROCEDURE DATE? WHAT DATE /DAY POST OP WAS THE REACTION NOTED? WAS ANY PRESCRIPTION STRENGTH MEDICATION PRESCRIBED TO ADDRESS THE ISSUE? PLEASE SPECIFY? IT WAS NOTED 2 DEBRIDEMENT PROCEDURES WERE PERFORMED. WAS ANY SURGICAL INTERVENTION PERFORMED? WERE ANY CULTURES TAKEN? RESULTS? HOW WAS THE WOUND CLEANED AND DRIED PRIOR TO PRINEO APPLICATION? PLEASE DESCRIBE HOW WAS THE ADHESIVE WAS APPLIED. WHAT PREP WAS USED PRIOR TO, DURING OR AFTER ADHESIVE USE? WAS A DRESSING PLACED OVER THE INCISION? IF SO, WHAT TYPE OF COVER DRESSING USED? WERE ANY PRE-OP CLEANSING PROCEDURES CHANGED RECENTLY? IF YES, PLEASE DESCRIBE. IS THE PATIENT HYPERSENSITIVE OR HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? IS THE PATIENT HYPERSENSITIVE TO PRESSURE SENSITIVE ADHESIVES? WAS PATIENT SCREENING DONE PRIOR THE PROCEDURE, E.G. CHECK PATIENT NOT ALLERGIC TO CYANOACRYLATE, FORMALDEHYDE, BAC, PRESSURE-SENSITIVE ADHESIVE? PATIENT DEMOGRAPHICS: INITIALS / ID, GENDER, AGE OR DATE OF BIRTH; BMI. PATIENT PRE-EXISTING MEDICAL CONDITIONS (IE. ALLERGIES, HISTORY OF REACTIONS). HAS THE PATIENT USED OR BEEN EXPOSED TO SIMILAR GLUES/AGENTS FOR REPAIR, CRAFTS, COSMETIC USE (LASHES, NAILS)? WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? PRODUCT CODE AND/OR LOT OF PRODUCT USED? CURRENT PATIENT STATUS. NAME OF SURGEON? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? IS PRODUCT AVAILABLE TO RETURN FOR ANALYSIS. NO PRODUCT IS AVAILABLE FOR RETURN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.