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 Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); Not Applicable (3189)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts to obtain the following additional information have been made.No response to date.The device have been made with no return to date.If the device or further details are received at a later date a supplemental medwatch will be sent.Please provide photos.Please describe how was the adhesive applied on the tape.What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? were any patch or sensitivity tests performed? what is the physicians opinion of the contributing factors to the reaction? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi; gender.Patient pre-existing medical conditions (ie.Allergies, history of reactions).

Event Description

It was reported a patient underwent a breast implant exchange and mastopexy on (b)(6) 2019 and topical skin adhesive was used.The patient had a reaction to adhesive: contact dermatitis, rash with blistering on bottom of each breast where dermabond applied, lateral chest and abdomen.The adhesive was removed, followed by prescription steroids and prescription steroid cream.Patient referred to dermatologist.Initial rash is getting better but not resolved.The product code and lot number are unknown.Additional information has been requested.

Manufacturer Narrative

(b)(4).The following additional information was requested and obtained: please provide photos.Provided please describe how was the adhesive applied on the tape what prep was used prior to, during or after prineo use? - glue painted on in 1 layer extending 1 cm past border on all sides as typical.Betadine surgical prep used prior, no other prep was a dressing placed over the incision? if so, what type of cover dressing used? - light gauze with no tape/adhesive is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? - no were any patch or sensitivity tests performed? - no what is the physicians opinion of the contributing factors to the reaction? - allergic dermatitis confirmed by dermatologist 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 patient pre-existing medical conditions (ie.Allergies, history of reactions) -jf, 61 year old female, bmi 24, allergies: atropine- reaction is dystonia, pmh of basal cell carcinoma and diverticulitis.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9279620
• MDR Text Key: 166817843
• Report Number: 2210968-2019-89510
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 01/02/2020
• Supplement Dates FDA Received: 01/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR