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Patient 1
(B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ATTEMPTS TO OBTAIN THE FOLLOWING INFORMATION HAVE BEEN MADE AND NO RESPONSE TO DATE. IF FURTHER DETAILS OR THE DEVICE ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ARE ANY PHOTOS OF WOUND AVAILABLE? INITIAL WOUND LACERATION CLOSURE DATE? PLEASE CONFIRM, IT WAS NOTED THE REACTION AND DEHISCENCE OCCURRED POST OP DAY 5 ON (B)(6) 2020? HOW WAS THE REACTION / DEHISCENCE TREATED (PRODUCT REMOVED; REOPERATION; RECLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. PLEASE INDICATE ANY MEDICAL OR SURGICAL INTERVENTIONS PERFORMED. PLEASE DESCRIBE HOW WAS THE ADHESIVE WAS APPLIED ON THE TAPE. WHAT PREP WAS USED PRIOR TO, DURING OR AFTER DERMABOND ADVANCED USE? WAS A DRESSING PLACED OVER THE INCISION? IF SO, WHAT TYPE OF COVER DRESSING USED? IS THE PATIENT HYPERSENSITIVE OR HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? IS THE PATIENT HYPERSENSITIVE TO PRESSURE SENSITIVE ADHESIVES? WERE ANY PATCH OR SENSITIVITY TESTS PERFORMED? DO YOU HAVE THE PRODUCT LOT NUMBER INVOLVED? WHAT IS THE PHYSICIANS OPINION OF THE CONTRIBUTING FACTORS TO THE REACTION? WHAT IS THE MOST CURRENT PATIENT STATUS? IS THE PRODUCT OR REPRESENTATIVE SAMPLE (PRODUCT FROM THE SAME LOT NUMBER) AVAILABLE FOR EVALUATION? PATIENT DEMOGRAPHICS: INITIALS / ID; AGE OR DATE OF BIRTH; BMI; PATIENT PRE-EXISTING MEDICAL CONDITIONS (IE. ALLERGIES, HISTORY OF REACTIONS). WAS PRINEO/DEMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.