MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

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

Patient Problems Pain (1994); Blister (4537); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information has been requested and received.What is the procedure date? (b)(6) 2021.Can you please clarify what was the quality issue experienced with dermabond prineo product? my knee gradually swelled and the swelling extended down to my ankle and to my upper thigh.Did you have an adverse event or skin reaction to the product? the swelling was so bad that my skin got very hot and it was hypersensitive to touch.I developed several blisters around the incision site.This surgery as to be a single overnight stay in hospital but due to reaction to dermabond, i remained in hospital for 4 nights.If yes, was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.Blood work to rule out infection.An ultrasound to rule out blood clots.I was given additional pain medication every 2 hours to control my pain.The adhesive closure was removed on (b)(6).If medication was required, please clarify if it was prescribed by a physician.I was still in hospital so yes it was prescribed by a physician have you been exposed to prineo/dermabond or other skin adhesives on a previous surgery or wound closure? no.This is my first exposure to dermabond.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Are photos available of the reaction? if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? no product is available for returned.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 knee replacement on (b)(6) 2021 and topical skin adhesive was used.Patient's knee gradually swelled and the swelling extended down to ankle and to upper thigh.Swelling and skin got very hot and it was hypersensitive to touch, developed several blisters around the incision site.Surgery was to be a single overnight stay in hospital but due to reaction to adhesive,, patient remained in hospital for 4 nights.Blood work to rule out infection and given additional pain medication every 2 hours to control pain.The adhesive closure was removed on (b)(6) 2021.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and obtained.Photos and the authorization to disclose information form received.Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.What medical and/or surgical intervention or treatment was performed to address the reaction and blisters? was a procedure performed to drain the blisters? it was noted bloodwork performed to rule out infection, are results available? 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? please describe how was the product applied? has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? 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 code and lot number? 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.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12868505
• MDR Text Key: 281200446
• Report Number: 2210968-2021-12044
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2021
• 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; Hospitalization