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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 01/01/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional information has been requested and received. If further details are received at a later date a supplemental medwatch will be sent. Please provide the following information: photo available of each patient? no, only the one. What was the procedure date? unknown. What date /day post op was the reaction noted? unknown. Please describe how was the adhesive was applied. Following the ifu: wound was approximated with hemostasis achieved. What prep was used prior to, during or after adhesive use? unknown. Was a dressing placed over the incision? if so, what type of cover dressing used? no. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown. Is the patient hypersensitive to pressure sensitive adhesives? unknown. Was patient screening done prior the procedure, e. G. Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? no. Patient demographics: initials /id, gender, age or date of birth; bmi. Patient in image is female; others are unknown. Patient pre-existing medical conditions (ie. Allergies, history of reactions). Unknown. Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown. Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown. Current patient status: topical steroids were used and patients recovered. 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.
 
Event Description
It was reported a patient underwent a pacemaker procedure on an unknown date in 2022 and topical skin adhesive was used. Patient had a rash forming on the skin where adhesive was used. Adhesive was used over the incision. Adhesive removed and treated with oral steroids. 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 Key14362456
MDR Text Key291481048
Report Number2210968-2022-03596
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 05/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2022
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 Received04/14/2022
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: 05/11/2022 Patient Sequence Number: 1
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