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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT Back to Search Results
Catalog Number CLR222US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Skin Irritation (2076)
Event Date 10/04/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts have been made to retrieve the device. 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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. How was the patient treated? date that prineo was removed? how was the patient treated when the prineo was removed? was there any additional medical or surgical intervention performed? what date did the reaction occur post op? were prescription steroids administered? were antibiotics prescribed ? 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? were any patch or sensitivity tests performed? do you have the lot number involved ? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation?.
 
Event Description
It was reported that a patient underwent spinal procedure on (b)(6) 2018 and topical skin adhesive was used. In recovery on neurology unit, a staff member removed the tape from the patient prior to discharge, thinking that it was a common dressing. The patient experienced inflammation, redness and infection at the application site. The patient returned to the facility and it was not reported what treatment was provided. Additional information has been requested.
 
Manufacturer Narrative
Product complaint #: (b)(4). Additional information was requested and the following was obtained: what are the contributing factors to the event? the specific information is unknown. It is possible that a sticky dressing may have been placed over the prineo and when the dressing was pulled off the prineo may have also pulled off. What is the most current patient status? it is unknown if the patient experienced an infection. Patient current condition is unknown.
 
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Brand NameDERMABOND PRINEO 22CM SKIN CLOSURE
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo PR
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8065145
MDR Text Key126972025
Report Number2210968-2018-77129
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 10/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received12/05/2018
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: 11/13/2018 Patient Sequence Number: 1
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