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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 Hypersensitivity/Allergic reaction (1907)
Event Date 04/07/2022
Event Type  Injury  
Event Description
It was reported a patient underwent a right total knee replacement on an unknown date in (b)(6) 2022 and topical skin adhesive was used.Patient experienced an allergic reaction upon 2nd exposure to adhesive.Allergy was discovered pod 14.Adhesive was removed and patient was treated with topical corticosteroid 0.05%.Was prescribed, additional information has been requested.
 
Manufacturer Narrative
Product complaint # (b)(4).Additional information: customer reference/po/service? (b)(6) hospital, did the patient experience a post-op device malfunction? no, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes, did the patient require revision surgery or hardware removal? no, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? topical corticosteroids 0.05% was prescribed, patient status/ outcome / consequences? yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? allergic reaction upon 2nd exposure to dermabond prineo post-tkr pod 14 was observed.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe.Topical corticosteroids 0.05% was prescribed, is the patient part of a clinical study? unknown.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.What was the procedure date? please describe how was the adhesive was applied.What prep was used prior to, during or after adhesive 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? was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? 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)? current patient status.No product is available for return.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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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 Key14437208
MDR Text Key292071722
Report Number2210968-2022-03875
Device Sequence Number1
Product Code OMD
UDI-Device Identifier10705031230996
UDI-Public10705031230996
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCLR222US
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/25/2022
Initial Date FDA Received05/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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