MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Catalog Number CLR602

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

Patient Problems Wound Dehiscence (1154); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Local Reaction (2035); Scar Tissue (2060); Fluid Discharge (2686)

Event Date 09/06/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information provided:the patient remained without any surgical wound infection and the scars continue to close at second intention.10 sessions of hyperbaric, dressing with protosan and alginate have already been performed, with good evolution.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Verify date of initial procedure (b)(6) 2021? reaction/wound dehiscence date (b)(6) 2021? what medical and/or surgical intervention was performed to address the wound dehiscence? please describe how was the adhesive was applied? has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? has the patient had prior exposure to dermabond, prineo or other skin adhesives? does the patient have allergies to medication, food, etc.? was an allergy test performed? if so, please provide results.What surgical preparation was used prior to, during, or after product use? are photos available? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? product lot number? how many prineo products were used during the procedure? no product is available for return.

Event Description

It was reported a patient underwent mammoplasty with a prosthesis and umbilical scar correction on (b)(6) 2021 and topical skin adhesive was used.On the fifth day of post op, reported a lot of itching in the scars, with an outflow of watery secretion through the applied glue.On the sixth postoperative day, surgeon examination, observed breasts with an area of hyperemia along the entire path of the scars where the glue was applied, both in breasts and in the umbilical scar and removed it.Upon removal, observed superficial epidermolysis (epidermis and superficial dermis) of the complete vertical scar in the right breast, partial on the left also in the vertical scar.Horizontal scars were only hyperemic.Umbilical region had complete dehiscence with deeper epidermolysis.Allergra 180mg anti-allergic starter.The patient was already using keflex 1g 12/12h and it was extended.Treatment started local dressing with dersani hidrogel and referred the patient to the hyperbaric chamber.There was a progressive and important improvement with the hyperbaric chamber.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• 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
• MDR Report Key: 12540363
• MDR Text Key: 273582486
• Report Number: 2210968-2021-08898
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2021
• 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
• Patient Age: 30 YR