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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 Problems Local Reaction (2035); Blister (4537); Skin Inflammation/ Irritation (4545)
Event Date 09/16/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional information was requested however not received. If further details are received at a later date a supplemental medwatch will be sent. Are any photos available of the reaction? what was the orthopedic procedure performed? what medical and/or surgical intervention or treatment was performed to address the reaction and blistering while hospitalized? how long was the patient hospitalized for the reaction? please describe how was the adhesive was applied? has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? does the patient have allergies to medication, food, etc. ? was an allergy test performed? if so, please provide results. What surgical preparation was used prior to, during, or after product use? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? product lot number? has the patient previously been 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? no product is available for return.
 
Event Description
It was reported a patient underwent an unknown orthopedic surgery on 9/15/2021 and topical skin adhesive was used. On (b)(6) 2021 a wide range of blisters developed on the distal side. After the patch was left as it was, on (b)(6) 2021, redness around the mesh patch and blisters worsened, resulting in extended hospitalization. Further details are not provided. No sample will be returned.
 
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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 Key12650471
MDR Text Key283303072
Report Number2210968-2021-09820
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeJA
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
Type of Report Initial,Followup,Followup
Report Date 01/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
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
Is the Reporter a Health Professional? No
Date Manufacturer Received12/09/2021
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: 10/18/2021 Patient Sequence Number: 1
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