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U.S. Department of Health and Human Services

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

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ETHICON INC. DERMABOND PRINEO 22CM SURGICAL SEALANT Back to Search Results
Catalog Number CLR222
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Purulent Discharge (1812); Inflammation (1932); Scarring (2061); Not Applicable (3189)
Event Date 06/10/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. Additional information received: what is the most current patient status? progressed to resolution but still experienced marked scaring. Patient pre-existing medical conditions (ie. Allergies, history of reactions). Patient has strong history of allergic reactions to chlorhexidine, penicillin, tetanus, msaids and bandages. What is the physicians opinion of the contributing factors to the reaction? surgeon believes to be a prineo reaction. Attempts have been made to obtain the following additional information, however not received to date: t was noted that antibiotics were prescribed and readmitted for wound management, was the reaction treated in any other manner (product removed; reoperation; reclosure; other prescription)? if so, please clarify. Please indicate any medical or surgical interventions performed. Please describe how was the adhesive was applied on the tape. 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? attempts have been made to obtain additional information. To date the device has not been returned and no additional information has been received. 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 a total knee replacement on (b)(6) 2019 and topical skin adhesive was used. On post op day 3, patient presented with marked skin reaction at the surgical site: inflammation, blisters, bruising and wound discharge. Was re-admitted to hospital for antibiotics and manage wound and reduce surgical site infection risk. Progressed to resolution but still experienced marked scaring. Additional information was requested.
 
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Brand NameDERMABOND PRINEO 22CM
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 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8846765
MDR Text Key152810619
Report Number2210968-2019-84933
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeAS
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
Report Date 07/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2020
Device Catalogue NumberCLR222
Device Lot NumberMHH085
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 Received08/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/18/2018
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: 07/31/2019 Patient Sequence Number: 1
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