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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 Contamination /Decontamination Problem (2895)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/23/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The following information was requested and no response has been received. To date the device has not been returned. If further details are received at a later date a supplemental medwatch will be sent. How the case was completed? were there any adverse patient consequences? is the device available for return to evaluate?.
 
Event Description
It was reported a patient underwent a total hip procedure on (b)(6) 2020 and surgical sealant was used. During surgery, it was noted the product had weird substance inside packaging that resembled blood. No patient consequences were reported. Additional information was 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
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10242062
MDR Text Key198108705
Report Number2210968-2020-05105
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,distri
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Model NumberCLR222US
Device Catalogue NumberCLR222US
Device Lot NumberPMR768
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 Received08/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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