DERMABOND PRINEO

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: DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE (CLR422US) : SIDE AFFECTED: RIGHT SIDE REASON PRODUCT IS NOT AVAILABLE: DISCARDED. LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. SUTURES/STRATAFIX. 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? YES_ DESCRIPTION ANTIHISTAMINE AND PREDNISONE. DID THE PATIENT/USER REQUIRE EXTENDED HOSPITALIZATION AS A RESULT OF THE EVENT? NO WHAT IS THE PATIENT¿S/USER¿S STATUS/OUTCOME FOLLOWING THE EVENT? IMPROVING WAS THERE A SIGNIFICANT DELAY? NO IF AVAILABLE, PROVIDE THE PRODUCT ORDER NUMBER (PO). DO YOU NEED PRODUCT PACKAGING TO SEND THE PRODUCT BACK? NO WOULD YOU LIKE A RETURN LABEL AT THE END OF THIS PROCESS? NO 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 INFECTION NAME OF SURGERY? WHAT WAS THE PROCEDURE DATE? WHAT DATE /DAY POST OP WAS THE REACTION NOTED? 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? 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.

Description of Event or Problem

IT WAS REPORTED A PATIENT UNDERWENT AN TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE IN 2026 AND TOPICAL SKIN ADHESIVE WAS USED. POST OP EXAM WITH ORTHOPEDIC TECHNICIAN REVEALED SKIN REACTION ON TKA CLOSED WITH ADHESIVE. THE DRESSING REMOVED APPROXIMATELY ONE WEEK AGO AND IS IMPROVING WITH ANTIHISTAMINE AND PREDNISONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.