DERMABOND PRINEO

Description of Event or Problem

IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2026 AND TOPICAL SKIN ADHESIVE WAS USED. THE PLASTIC SURGEON SAID ONE OF HIS PATIENTS HAD A REACTION TO ADHESIVE. HE STATED THAT IT LOOKED LIKE A RASH. PATIENT WENT TO ER AND TREATED WITH STEROIDS. 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: CLR22US: ETHICON SIDE AFFECTED: UNKNOWN QUANTITY AFFECTED: 1 QUANTITY AVAILABLE TO BE RETURNED: 0 REASON PRODUCT IS NOT AVAILABLE: IMPLANTED. LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. UNKNOWN AT THIS TIME. WAS THERE ANY REPORTED PATIENT OR USER HARM? YES. DID THE PATIENT/USER REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF THE EVENT? UNKNOWN. DID THE PATIENT/USER REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE EVENT? UNKNOWN. WHAT IS THE PATIENT¿S/USER¿S STATUS/OUTCOME FOLLOWING THE EVENT? UNKNOWN. WAS THERE A SIGNIFICANT DELAY? UNKNOWN. IF AVAILABLE, PROVIDE THE PRODUCT ORDER NUMBER (PO). DO YOU NEED PRODUCT PACKAGING TO SEND THE PRODUCT BACK? NO. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. WHAT IS THE PROCEDURE NAME? IT WASN'T ABLE TO ASK THE TYPE OR DATE PF THE PROCEDURES. WHAT IS THE PROCEDURE DATE (DD/MM/YYYY)? IT WASN'T ABLE TO ASK THE TYPE OR DATE PF THE PROCEDURES. WHAT DATE DID THE REACTION OCCUR ON (DD/MM/YYYY)? IT WASN'T ABLE TO ASK THE TYPE OR DATE PF THE PROCEDURES. DO YOU HAVE ANY PICTURES OF THE REACTION? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION MEDICATION)? IF SO, PLEASE SPECIFY. IF MEDICATION WAS REQUIRED, PLEASE CLARIFY IF IT WAS PRESCRIPTION STRENGTH. HE SAID ALL BUT ONE PATIENT HAD LOCALIZED REACTIONS. HOWEVER, ONE PATIENT HAD A SEVERE REACTION AND WENT TO THE ER. STEROIDS RESOLVED THE ISSUE. I SPOKE BRIEFLY WITH THE SURGEON AND HE SAID THE REACTION HAS HAPPENED ON SEVERAL CASES. I HAVE NO FURTHER INFORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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? CURRENT PATIENT STATUS. NAME OF SURGEON? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? 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.