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

Catalog Number CLR222US

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

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Date 05/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information has been requested, the following was received: please describe how was the adhesive was applied on the tape.As per ifu.What prep was used prior to, during or after prineo use? water to clean incision area before prineo.Was a dressing placed over the incision? if so, what type of cover dressing used? no.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? not known during usage.Is the patient hypersensitive to pressure sensitive adhesives? not known.Were any patch or sensitivity tests performed? no.Do you have the product lot number involved? nope.What is the physicians opinion of the contributing factors to the reaction? prineo is the contributing factor as the rashes is within the prineo polyester mesh.What is the most current patient status? skin healed when patient returned at pod 12.Is the product or representative sample (product from the same lot number) available for evaluation? no.Patient demographics: initials / id; age or date of birth; bmi; gender? no details.Pdpa (personal data privacy act).Patient pre-existing medical conditions (ie.Allergies, history of reactions): no history.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no.First time user.To date device not received.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported a patient underwent an wound closure for a back lump resection on (b)(6) 2019 and topical skin adhesive was used.On post operative day 3, the incision area was itchy and developed an allergic reaction to it.It was noted the surgeon used adhesive as a skin closure device, surgeon only closed the subcutaneous fat layer and did not close the subcuticular layer.Hence surgeon was reluctant to remove the adhesive.As this would expose the risk of skin infection to the patient.Surgeon subsequently prescribed antihistamines to the patient and sent patient home.Additional information was requested.

• 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 PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8675125
• MDR Text Key: 147203688
• Report Number: 2210968-2019-82468
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Report Date: 05/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2019
• 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