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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE SURGICAL SEALANT Back to Search Results
Model Number CLR602US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rash (2033)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). The following information has been requested however not obtained to date. To date the device has not been received. If the further details are received at a later date a supplemental medwatch will be sent. Date of procedure? date of reaction? are any photos of the reaction available? what product was used prineo clr602 or another? what prep was used prior to, during or after adhesive use? please describe how was the adhesive was applied. Was a dressing placed over the incision? if so, what type of cover dressing used? it was noted steroid cream was prescribed, type and dosage? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? patient demographics: initials / id, gender, age or date of birth; bmi? patient pre-existing medical conditions (ie. Allergies, history of reactions), does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? what is the most current patient status?.
 
Event Description
It was reported a patient underwent an spine surgery on unknown date in 2020 and topical skin adhesive with mesh was used. Post operatively the patient presented with a skin rash where the adhesive mesh was applied to the incision. The patient was treated with a steroid cream. The patient is doing fine. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO 60CM 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
9082183429
MDR Report Key10842420
MDR Text Key216318671
Report Number2210968-2020-09053
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152490
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLR602US
Device Catalogue NumberCLR602US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2020
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: 11/16/2020 Patient Sequence Number: 1
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