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 Problem Reaction (2414)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The following additional information was requested, however not received to date: please verify the event information above for accuracy.How are you feeling? 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? if so, please provide your surgeon¿s name, contact email information and sign authorization to use or disclose information form.Attempts to obtain additional information and the device have been made with no response to date.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.

Event Description

It was reported a patient underwent a hip replacement on 6/11/2019 and topical skin adhesive was used.After the procedure, the patient has had a systemic allergic reaction to the adhesive.Patient was prescribed antiobiotic, which initially cleared up the allergic reaction but the reaction returned after the antiobiotic regime was completed.No other information is known.No product to be returned.Additional information has been requested.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 2/18/2020.The following additional information received: please verify the event information above for accuracy.I was prescribed very high doses of prednisone, starting at 80mg (not antibiotics).I was tested at the ¿national jewish health hospital¿ in denver for allergies to the dermabond prineo and had a very severe reaction.Photo provided.Please note that we are requesting a signed consent form to contact your physician for more clinical information to be used for a product quality complaint investigation the physician that performed the surgery: (b)(6) md.The physician that performed the allergy testing: dr.(b)(6) md, msph.How are you feeling? it has been over 7 months since my surgery.I have been in severe pain, the rash is unbearable.I am suffering from itching, a terrible constant burning sensation, a rash that was initially diagnosed as shingles and then shingles was ruled out when the rash, just 2 days later spread to other parts of my body, including my face, hands, stomach, back, and my other leg (the one that didn¿t have any surgery done on it).When on prednisone, the rash seemed to clear up and came back a couple of weeks after stopping prednisone.Right now i have been off of prednisone for 4 weeks and all the symptoms are coming back.Photo.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? yes.

Manufacturer Narrative

Product complaint # (b)(4).Attempts to obtain the following information has been performed but not received.If the further details are received at a later date a supplemental medwatch will be sent date of reaction? was there any treatment provided (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed)? if so, please clarify please indicate any medical or surgical interventions performed.What was the date/day post op the prineo sloughed off or prineo removed? please describe how was the adhesive was applied.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? is the patient hypersensitive to pressure sensitive adhesives? were any tests performed? what is the physicians opinion of the contributing factors to the reaction? 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: 9567091
• MDR Text Key: 185899624
• Report Number: 2210968-2020-00216
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2019

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: 12/13/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 01/23/2020; 03/18/2020
• Supplement Dates FDA Received: 02/18/2020; 03/18/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention