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 Itching Sensation (1943); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: what was the name of the procedure? -used in almost all breast and abdominal procedures so this is not just an exclusive reaction in one patient and one procedure.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? there is no relevance to use of antibiotics as each patient gets a perioperative dose.Were prescription steroids administered? what medical/surgical intervention was provided? what is the current condition of the patient? please describe in more detail "upon second use"? the reaction to the glue is in most cases developing around 5 days after application and causing intense itch redness and at times blistering exactly around the site of glue application.In some individuals they have undergone a reconstructive procedure in the past and prineo has been applied, however when they return 1 or 2 years to finalise their reconstruction, they are reacting to the glue.We have resorted in prescribing betnovate ointment and piriton , and only upon removal of the glue does the reaction settle after around 2 days.I have photographic evidence of the reaction.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts will be made to obtain additional information.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date and topical skin adhesive was used.Upon second use of the device when patient returns 1 or 2 years to finalize reconstruction procedure, the patient is reacting to the device and required immediate attention.The reaction to the device developed in around 5 days after application and caused intense itch redness and at times blistering exactly around the site of glue application.The patient was prescribed betnovate ointment and piriton.It was reported that only upon removal of the glue does the reaction settle after around 2 days.Additional information will be requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 5/19/2020.Additional information was requested, however not received to date.If the device or further details are received at a later date a supplemental medwatch will be sent.How many patient events? photo of reaction? procedure date? date reaction noted? was there any other treatment provided (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed) in addition to steroids and antibiotics? if so, please clarify.Please indicate any medical or surgical interventions performed.Please describe how was the adhesive was applied.What prep was used prior to, during or after dermabond 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? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product lot available or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi; patient pre-existing medical conditions (ie.Allergies, history of reactions) was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?.

• 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: 9824953
• MDR Text Key: 188629174
• Report Number: 2210968-2020-01986
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention