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Patient 1
(B)(4). 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. PLEASE CONFIRM THE INITIAL LAP CHOLE PROCEDURE DATE WAS (B)(6) 2020. WHAT DATE DID THE REACTION AND OCCUR POST OP? PLEASE CONFIRM ON WHAT DATE WAS THE PRODUCT WAS REMOVED AND STEROID CREAM APPLIED. WAS THERE ANY OTHER TREATMENT PROVIDED (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. 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? 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.