MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM; SURGICAL SEALANT

Catalog Number CLR222

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

Patient Problems Rash (2033); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested and the following was obtained: did the patient experience a post-op device malfunction? no.Did the patient experience an adverse event? yes.Did the patient require revision surgery or hardware removal? no.If no, was there any additional medical intervention required? removal of prineo and local steroids.Patient status/ outcome / consequences yes.Patient consequence description/was there a clinical outcome experienced by the patient? reported skin reaction.Was other medical intervention required: yes.If yes, describe steroid cream.Photos available? no.Can you confirm date/approx.How long did the reaction occur post op? noted approx.8-10 days post op.What prep was used prior to, during or after prineo use? chlorhexidine.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? not that dr was aware.Were any patch or sensitivity tests performed? no.What is the physician¿s opinion of the contributing factors to the reaction? allergic chemical reaction to the product.Patient demographics: initials / id; age or date of birth; bmi; gender ¿ will try to obtain.Patient pre-existing medical conditions (ie.Allergies, history of reactions) - will try to obtain.For female patients ask: was the patient exposed to similar products, such as artificial nails? no.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.What is the most current patient status? rash has settled.Dr also reported patient now approximately 3 weeks post operation, but could not recall on the phone the day of the procedure.He also noted that the patient was likely to have been operated on at different hospital but couldn't be sure.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 total knee replacement on an unknown date in (b)(6) 2019 and topical skin adhesive was used.A skin reaction was noted approximately 8-10 days post operation.It was treated with removal of adhesive and a local steroid cream.The most current patient status noted that rash has settled.

• Brand Name: DERMABOND PRINEO 22CM
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8437338
• MDR Text Key: 139353198
• Report Number: 2210968-2019-79580
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• 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