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

Catalog Number CLR222US

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested however no response has been received: are the two photos provided from the same patient? procedure name? initial procedure date? how was the reaction treated (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed)? if so, please clarify.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? was the site cultured? if so, what bacteria were identified? 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? do you have the numbers involved ? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? 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)? was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? attempts to obtain the following information have been made with no response to date.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 laparoscopic sleeve gastrectomy on an unknown date and topical skin adhesive was used.The adhesive was used to close the trocar ports with unknown suture and the physician assistant used adhesive to seal the sutured incisions.The patient was discharged and returned, post operatively, six to eight days later, with an allergic reaction to the adhesive, with redness and blisters.The doctor removed the adhesive and prescribed benadryl.Additional information has been requested.

Manufacturer Narrative

Product complaint #: (b)(4).Attempts to obtain the following information have been made and the following was obtained: no further information is available.

• Brand Name: DERMABOND PRINEO 22CM SKIN CLOSURE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8792777
• MDR Text Key: 151104393
• Report Number: 2210968-2019-84317
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention