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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 CLR222
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Itching Sensation (1943); Blister (4537); Swelling/ Edema (4577)
Event Date 12/01/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). Device not returned. Additional information has been requested and obtained. If further details are received at a later date a supplemental medwatch will be sent. What is the procedure date? tkr. What date did the reaction occur on? approx. 1 week post-op. What does the reaction look like and how large of an area does the reaction cover? n/k. Do you have any pictures of the reaction? no. Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify. Prescriptiontopical steroid used. What is the most current patient status? n/k. Can you identify the lot number of the product that was used? not provided was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? n/k. Please describe how the adhesive was applied. Unknown. What prep was used prior to, during or after prineo use? betadine. Was a dressing placed over the incision? if so, what type of cover dressing used? unknown. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown. Is the patient hypersensitive to pressure sensitive adhesives? unknown. Were any patch or sensitivity tests performed? no. Patient demographics: initials / id, gender, age or date of birth; bmi: unknown. Patient pre-existing medical conditions (ie. Allergies, history of reactions): unknown. Has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown. Surgeon has been using product for a long time. No product will be returned.
 
Event Description
It was reported a patient underwent a total knee replacement on an unknown date in december 2020 and topical skin adhesive was used. About 1 week post operatively, patient had inflammation, blistering, itchiness, and swelling where the adhesive was placed. Prescription topical steroid administered. 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.
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 Key11593134
MDR Text Key243918180
Report Number2210968-2021-02906
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLR222
Device Catalogue NumberCLR222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/30/2021 Patient Sequence Number: 1
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