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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 Skin Irritation (2076); Not Applicable (3189)
Event Date 12/09/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts were made to obtain information, no response has been received to date. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Was another type of wound closure required to address the wound? what prep was used prior to, during or after prineo use? how many layers of adhesive were used over during application? was a dressing placed over the incision? if so, what type of cover dressing used? what is the physicians opinion of the contributing factors leading to hospitalization? patient demographics: initials / id; age or date of birth; bmi, patient pre-existing medical conditions (ie. Allergies, history of reactions). Current status of patient? to date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported a patient underwent incisional hernia repair on (b)(6) 2019 and topical skin adhesive was used. Two weeks post operatively, the patient returned with serious contact dermatitis and was admitted to hospital. Patient treated with oral steroids treated by dermatologist. 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
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9530360
MDR Text Key185790202
Report Number2210968-2019-91384
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeSN
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,Followup,Followup
Report Date 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2020
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: 12/30/2019 Patient Sequence Number: 1
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