DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE

Description of Event or Problem

REDNESS ON BOTH BREASTS AROUND SURGICAL SITES. ALSO, BOTH HIPS WHERE DOG-EARS (SKIN FLAPS) TAKEN ALSO HAS REDNESS. SEEN IN CLINIC ON (B)(6) - SHE'D BEEN EXPERIENCING ISSUES SINCE EARLIER THAT WEEK APPROX. ON (B)(6). SEEN AGAIN ON (B)(6) - PINK/REDNESS AND SPOTTING ON HIPS AND ARM. ROSY RED CHEEKS, HANDS APPEARED LIKE CONTACT DERMATITIS.

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 HAS BEEN REQUESTED AND RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT IS THE PROCEDURE NAME? BREAST SYMMETRY AND LIPOFILL. WHAT IS THE PROCEDURE DATE (DD/MM/YYYY)? ON (B)(6) 2026. WHAT DATE DID THE REACTION OCCUR ON (DD/MM/YYYY)? APPROX ON (B)(6) 2026. WHAT DOES THE REACTION LOOK LIKE AND HOW LARGE OF AN AREA DOES THE REACTION COVER? REDNESS ON BOTH BREASTS AROUND SURGICAL SITES. ALSO, BOTH HIPS WHERE DOG-EARS (SKIN FLAPS) TAKEN ALSO HAS REDNESS. PINK/REDNESS AND SPOTTING ON HIPS AND ARM. ROSY RED CHEEKS APPEARED LIKE CONTACT DERMATITIS. EXTREME ITCHING SENSATION. DO YOU HAVE ANY PICTURES OF THE REACTION? NOT AVAILABLE. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION MEDICATION)? IF SO, PLEASE SPECIFY. PRODUCT REMOVED IN DRESSING CLINIC, CLEANED OFF. NO FURTHER DRESSINGS APPLIED. ANTIHISTAMINES AND TOPICAL STEROID CREAM APPLIED. IF MEDICATION WAS REQUIRED, PLEASE CLARIFY IF IT WAS PRESCRIPTION STRENGTH. ANTIHISTAMINES - CLORPHFENAMINE. 4MG, 4X PER DAY. BETNAVATE 0.1%. CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCT THAT WAS USED? NOT AVAILABLE. WHAT IS THE MOST CURRENT PATIENT STATUS? PATIENT UNHAPPY WITH SURGICAL EXPERIENCE. REVIEWED IN CLINIC AGAIN. WAS PRINEO/DERMABOND OR SKIN ADHESIVE USED ON THE PATIENT IN A PREVIOUS SURGERY OR WOUND CLOSURE? YES, DIEP SURGERY. NO OBSERVED REACTION WITH PREVIOUS SURGERY. 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. WAS THE HIP AREA COVERED WITH PRINEO? WHERE WAS PRODUCT USED? WAS ANY SURGICAL INTERVENTION PERFORMED? WHEN WAS THE PRINEO PRODUCT REMOVED FROM THE PATIENT? WERE ANY CULTURES TAKEN? RESULTS? PLEASE DESCRIBE HOW WAS THE ADHESIVE WAS APPLIED. HOW WAS THE WOUND CLEANED AND DRIED PRIOR TO PRINEO APPLICATION? 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? IS THE PATIENT HYPERSENSITIVE OR HAVE ALLERGIES TO CYANOACRYLATE OR FORMALDEHYDE? IS THE PATIENT HYPERSENSITIVE TO PRESSURE SENSITIVE ADHESIVES? DOES THE PATIENT HAVE ALLERGIES TO MEDICATION, FOOD, ETC.? 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 \ 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.