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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 Problem Rash (2033)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). The surgeon also informed representative that he has been using medtronic suture (biosyn) during this time and has had wound complications he feels is related to this suture (dehiscence and infection). Additional information has been requested however, not received. If further details are received at a later date a supplemental medwatch will be sent 2 photos were received. Are the photos of 1 patient or more? which file corresponds to each photo? procedure name? procedure date? what was the date of the reaction, day post op? please describe how was the adhesive was applied. What prep was used prior to, during or after prineo 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? were any patch or sensitivity tests performed? patient demographics: id, gender, age or date of birth; bmi does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails) was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? do you have the product code and /or lot number used? current patient status. No product is available for return.
 
Event Description
It was reported an adolescent patient underwent an orthopedic procedure on an unknown date and topical skin adhesive was used. Patient returned with a rash in the area adhesive was used. Rash treated with 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
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12333715
MDR Text Key267070167
Report Number2210968-2021-07418
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2021
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: 08/17/2021 Patient Sequence Number: 1
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