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U.S. Department of Health and Human Services

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

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ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT Back to Search Results
Model Number CLR222US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rash (2033)
Event Date 09/15/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional information has been requested however not received. If further details are received at a later date a supplemental medwatch will be sent. Are photos available of the reaction? date of surgical procedure? if product was removed, date of removal? does the patient have allergies to medication, food, etc. ? was an allergy test performed? if so, please provide results. What surgical preparation was used prior to, during, or after product use? please describe how was the product applied? has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? has the patient had prior exposure to dermabond, prineo or other skin adhesives? please describe type and dosage to treat the reaction including start date and results. Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure other relevant patient history/concomitant medications? surgeon¿s name? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? product lot number? no product available for return.
 
Event Description
It was reported a patient underwent a total knee replacement on an (b)(6) 2021 and topical skin adhesive was used. Patient presented on day 5 post op with "severe red rash over the entire knee. Follow up was office visit and steroids' on day 5. On day 12 breaking out all over. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
Type of DeviceSURGICAL 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 Key12829412
MDR Text Key285780638
Report Number2210968-2021-11600
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLR222US
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/17/2021 Patient Sequence Number: 1
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