MAUDE Adverse Event Report: ETHICON INC. DERMABOND ADVANCED UNKNOWN PRODUCT; ADHESIVE, TOPICAL SKIN

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

Patient Problems Wound Dehiscence (1154); Erythema (1840); Inflammation (1932); Itching Sensation (1943); Fluid Discharge (2686); Blister (4537); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 01/11/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: (b)(4) - device not returned.Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.To correct the summary that i received, my initial reaction was noted on post op day 5 when i noticed some drainage on my dressing.Not post op day 3 that was probably the initial dehiscence of the incision.The next day post op day 6 there was more drainage on the gauze dressing.I was instructed by the surgeon not to remove the dressing until post op day 10 therefore i left the dressing on.On post op day 7 i could not stand the itchiness and i wanted to see what was going on so i removed the dressing to expose a red, swollen, itchy open suture line with visible serosanguinous drainage and blister link vesicles along the length of both sides of the incision.I was unable to contact the physician or his office until post op day 11 since the office was closed for mlk weekend and i was unable to contact anyone due to problems with their phone lines.On day 11 i saw a nurse in the ortho office.Office nurse tried to remove the dermabond with alcohol in the office.She sent a photo to the md and he confirmed that i was having an allergic reaction to the dermabond.He gave me 7 days of antibiotics.Why? due to an open wound probably even though it was not producing purulent drainage.And 6 day pack of prednisone.I was self medicating with bendery 75 mg almost every 4-6 hours for 10 days.He also put me on bed rest and stopped my physical therapy until the incision dried up and closed.That happened on post op day 18.I do not have a copy of the operative report.I will give you permission to speak to my surgeon.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.

Event Description

It was reported a patient underwent a partial knee replacement on (b)(6) 2023 and topical skin adhesive was used.5 days post operation of a the patient presented with a severe reaction to the adhesive.The incision is inflamed, swollen, hot and red.The incision has also dehisced and is leaking fluid.Patient also has small little blisters that are oozing around the incision.Patient is currently taking orally benadryl, predsone, clindamycin.Patient is applying benadryl gel topically around the suture line but not directly on it.Adhesive was partially removed but some remains along the suture line.Patient currently on bed rest awaiting the incision to close.Patient currently on bed rest awaiting the incision to close.Additional information has been requested.

• Brand Name: DERMABOND ADVANCED UNKNOWN PRODUCT
• Type of Device: ADHESIVE, TOPICAL SKIN
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16390123
• MDR Text Key: 309732103
• Report Number: 2210968-2023-01192
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention