MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE; SURGICAL SEALANT

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cellulitis (1768); Erythema (1840); Hematoma (1884); Skin Irritation (2076); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: "how was the device applied to the incision please describe, how the adhesive was applied on the tape, what prep was used prior to product application? no information.What was the location and incision size of the application? on hip.Size is unknown.Was a dressing placed over the incision? if so, what type of cover dressing used? dressing wasn't used.What does the reaction look like and how large of an area does the reaction cover? the skin became red in size of about 5 to 7 cm in distal side.Do you have any pictures of the reaction? no photo is available.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.The product was removed on (b)(6).The antibacterial drug cravit® intravenous drip infusion was started and treatment was done with acrinor compress on (b)(6).Can you identify the lot number of the product that was used? no information.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no.For female patients, were they exposed to similar products, such as artificial nails? no information.What is the most current patient status? unknown.Patient demographics: initials/id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no information.".

Event Description

It was reported that a patient underwent a total hip arthroplasty procedure on (b)(6) 2018 and topical skin adhesive was used during closing the surgical wound on the epidermis of the hip joint.On (b)(6) 2018, the patient was discharged from the hospital.Lixiana tablets were administered two to eleven days after the surgery.On (b)(6) 2018 the product was removed.There was no problem in the skin.On (b)(6), the skin was red in size of about 5 to 7 cm on the distal side.On (b)(6) 2018, the patients skin became red on the distal side of the incised part.The affected area also had heat.On (b)(6) 2018, the patient was administered antibacterial drug cravat intravenous drip infusion and treatment was done with acrinor compress.The reddening of the skin then subsided.The intravenous drip was taken under consideration to stop.After (b)(6) 2018, the patient was treated as an outpatient.On (b)(6) 2018 the patient received outpatient antibiotics.The surgeon opines that the causal relationship between the topical skin adhesive and the adverse event is unknown and it is unknown whether it is an inflammation or infection.The patient had no allergies.The surgeon was trying to prevent oozing of exudate by suturing with short pitch, but a little exudate came out.There is a possibility that the exudate was contained, and it became a hematoma, which caused the adverse event.Usually, aquacel is used to absorb exudate.Cellulitis was suspected.Additional information has been requested.

Manufacturer Narrative

Product complaint #: (b)(4).Additional information was requested and the following was obtained: date that patient was initially discharged from the hospital: (b)(6) 2018.Did the patient have prolonged hospitalization due to the skin reaction ?: no.Was the patient re-hospitalized?: no.If yes, what dates were the patient re-hospitalized?: na.

• Brand Name: DERMABOND PRINEO 22CM SKIN CLOSURE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO; 982 road 183 km 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7883852
• MDR Text Key: 120523116
• Report Number: 2210968-2018-75873
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention