DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222US

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-26 for DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE CLR222US manufactured by Ethicon Inc..

Event Text Entries

[181715742] (b)(4). Attempts to obtain the following information have been made with no response to date. If further details are received at a later date a supplemental medwatch will be sent. Date of total knee replacement surgery? Date of reaction? 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? What is the physicians opinion of the contributing factors to the reaction? 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? What is the most current patient status? 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.
Patient Sequence No: 1, Text Type: N, H10


[181715743] It was reported a patient underwent an unknown orthopedic procedure on an unknown date and topical skin adhesive was used. A skin reaction / irritation to topical skin adhesive. Put on steroids to remove rash. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-01529
MDR Report Key9757308
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-26
Date of Report2020-02-04
Date of Event2020-01-01
Date Mfgr Received2020-02-04
Date Added to Maude2020-02-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone6107428552
Manufacturer G1ETHICON INC.-SAN LORENZO PR
Manufacturer StreetROAD 183, KM. 8.3
Manufacturer CitySAN LORENZO 00754
Manufacturer Country*
Manufacturer Postal Code00754
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
Generic NameSURGICAL SEALANT
Product CodeOMD
Date Received2020-02-26
Model NumberCLR222US
Catalog NumberCLR222US
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-26

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