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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 CLR222
Device Problem Material Separation (1562)
Patient Problems Wound Dehiscence (1154); Fluid Discharge (2686)
Event Date 08/18/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Device not returned. Additional information has been requested and obtained. If further details are received at a later date a supplemental medwatch will be sent. Did wound dehiscence occur? ans- yes. Was there any medical or surgical intervention performed (re-operation; re-closure; prescription medication)? if so, please specify. Ans-yes, dr. Did reclose the skin layer with the help of ahv6(dermabond) & steristrips(3m). If medication was required, please clarify if it was prescribed by a physician. Ans-unknown. Do you have any pictures of the dermabond prineo before it was removed? ans-no. What is the most current patient status? ans- patient is fine now. As per discussion dr. Didn't close subcuticular layer on right leg knee. In right leg knee, he closed only up to subcutaneous fat layer and applied prineo. In left leg knee dr. Closed upto subcuticular layer & applied prineo. It gave good results. Dr. Said that if he applied prineo after closing all layers (upto subcuticular) in his joint procedure, there is no worth of this product. There was some amount of active drainage on right leg knee post op. According to him, drainage will definitely be there in all joint procedures but the amount may differ or may vary patient to patient based on their profile and condition. Dr. Agreed to connect with any specialist ortho surgeon, who has good knowledge of fixing/ applying the dermabond prineo to understand it's indication. Product not available for return. A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
It was reported a patient underwent an right total knee replacement procedure on (b)(6) 2021 and topical skin adhesive was used. Post op day 2, the adhesive was not affixed properly on right side of knee and got removed. He found this situation when he was on routine checkup in icu. The wound dehisced. The wound was addressed with more adhesive and steri strips. 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.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12507378
MDR Text Key272523357
Report Number2210968-2021-08696
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeIN
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
Report Date 08/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/23/2020
Device Model NumberCLR222
Device Catalogue NumberCLR222
Device Lot NumberQLBDXE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2021
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

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