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 Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/30/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested however not received to date.If further details are received at a later date a supplemental medwatch will be sent did the event occur during one or multiple patient procedures? what is the total number of procedures? have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).If the mentioned events (3 for last year and 6 for this year) haven't been previously reported, please open additional files accordingly (1 product complaint needs to be created for each patient event).Did the pictures provided correspond to the same patient? if no, please indicate to which patient each photo corresponds to.4 photos were attached, which appear to be from multiple patients.Please advise which photo(s) belong to this patient event ((b)(4)) and provide reference to other related patient(s)/file.Procedure name? date of procedure? date of reaction? an event/reaction date of (b)(6) 2021 was entered on (b)(6) 2021, please clarify? 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 previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? what is the current status of the patient? product is not available for return.

Event Description

It was reported a patient underwent an unknown procedure on unknown date and topical skin adhesive was used.Patient experienced reaction with itching, inflammation, skin turns to red on the mesh site.Allergic reaction on patient, after prineo was removed from the surgical site after 2 weeks after surgery.Steroid prescribed.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11887976
• MDR Text Key: 266430335
• Report Number: 2210968-2021-05009
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• 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
• Date Manufacturer Received: 04/30/2021
• 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