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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
Catalog Number CLR222
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Irritation (2076)
Event Date 08/15/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). The following information has been requested with no response to date: photo of reaction? date of procedure? did the patient have a confirmed infection? were any tests performed? if yes, provide details and results? patient symptoms manifestations (location, severity, appearance, systemic or local reaction)? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra-operation? 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? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? 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.
 
Event Description
It was reported a patient underwent a total hip arthroplasty on and unknown date and topical skin adhesive was used. Patient was discharged post op (b)(6) 2019 progressing well. Returned to out patient clinic / surgeons rooms 7 days post op with reaction on 8/15/2019. Patient had a wound reaction & risk of surgical site infection. Current treatment removal of dressing and antibiotics. 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 0151
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 08876-0151
6107428552
MDR Report Key8995145
MDR Text Key158917098
Report Number2210968-2019-87045
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 08/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2020
Device Catalogue NumberCLR222
Device Lot NumberMLA146
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/30/2018
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: 09/11/2019 Patient Sequence Number: 1
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