MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222US

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

Patient Problems Local Reaction (2035); Blister (4537)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The following information has been requested and obtained.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Was there any medical or surgical intervention performed to threat the reaction (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? yes.If so, please clarify.Patient wan put on additional abx-keflex and bactrim last week.What is the most current patient status? pat was admitted to the hospital in cheyenne on (b)(6) 2020 and released on 12.20.20.While in the hospital they gave him steroids and iv bene drill and the patient also suspected mrsa infection.Can you identify the lot number of the product that was used? no.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no.The following information has been requested however not received.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Please describe how 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 patch or sensitivity tests performed? patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? what is the current status of the patient?.

Event Description

It was reported a patient underwent an acl revision procedure on (b)(6) 2020 and topical skin adhesive with mesh was used.About one week post op, the patient experienced redness and irritated blisters around the application site.Patient was put on additional abx-keflex and bactrim.Patient was admitted to the hospital on (b)(6) 2020 and released on (b)(6) 2020.While in the hospital administered steroids and iv benedryl.Patient also suspected mrsa infection.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11195848
• MDR Text Key: 227731193
• Report Number: 2210968-2021-00459
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR222US
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2020
• 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