MAUDE Adverse Event Report: ETHICON LLC DERMABOND PRINEO SKIN CLOSURE SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Skin Discoloration (2074); Swelling (2091); Fluid Discharge (2686)

Event Date 02/21/2018

Event Type  Injury  

Event Description

Total knee replacement of rt knee, the ethicon prineo system was used as a part of closure of surgical wound.Soon after surgery all expected swelling began to resolve except around the knee area and on post op day 6, i noticed a rash along the edges of dressing with severe itching.By po day 8, there was serous drainage, increasing rash and my ears and forehead became red and itchy.This was reported to my provider, i had started taking benadryl and was told to continue.On po day 9, i stopped taking any medication except tylenol.By po day 11, the rash covered my knee, spreading lightly to mid-thigh, my face was completely red and rashened.My ear canals became tight with swelling and itching of my nose and roof of mouth.At this point, i stop all meds, including my blood thinner.I applied generous quantities of triamcinolone to my face, ears, neck and chest.On po day #12, i saw my medical provider who recommended stronger triamcinolone cream and recommended a stat derm appointment (which i did not schedule).On po day 13, i saw my orthopedic surgeon, who removed the dressing, noting serous blisters and redness and swelling all along the incision line.He did believe that it was a reaction to prineo and that prophylactic antibiotics be used, bactroban ointment be used as a barrier and that i continue taking benadryl.Po day 14, the rash remains present at the surgical site, my face and neck and up to mid thigh.The wound is drier with less erythematous color, but the itching remains intense.I have no known allergies and no unusual reaction to tape or other medical adhesives.My left total knee which was done in 2015 and closed with sutures and staples.I am an rn with a surgical and er background, so prior exposure to dermabond has occurred.Surgically, the knee appears to be functioning normally.There is no fever today and though the itching is intense.I believe removing the prineo strip and as the glue becomes less present in the area, the reaction is lessening.Because of the oozy lesions and irritation, we did not use aggressive methods to remove the remaining glue.The use of ointments is resulting in the remaining glue becoming granular and flaking off.I did take pictures.

• Brand Name: DERMABOND PRINEO SKIN CLOSURE SYSTEM
• Type of Device: DERMABOND
• Manufacturer (Section D): ETHICON LLC
• MDR Report Key: 7326976
• MDR Text Key: 102114735
• Report Number: MW5075760
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AMBIEN; ASPIRIN STARTING (B)(6) 2018.; MOBIC (HELD SINCE SURGERY). ; OTC IRON. ; OTC MEDS: BENADRYL; RX MEDS: SPIRONOLACTONE (ACNE); SINCE SURGERY ON (B)(6) 2018 I HAVE USED OXYCODONE (STOPPED), TRAMADOL (STOPPED, THEN RESUMED AFTER THE CAUSATIVE FACTOR FOR THE RASH WAS DETERMINED TO BE DERMABOND). TRIAMCINOLONE CREAM TOPICALLY TO ALL RASHENED AREAS EXCEPT OVER SURGICAL WOUND.
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 100