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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); Itching Sensation (1943); Rash (2033); Skin Irritation (2076)
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. Additional information was requested and the following was obtained: do you have any photos? no. Was any additional dressing placed on top of the prineo22? xeroflo, sterile 4x4¿s, ace wrap? current patient status - unknown. We have not had contact with the patient since (b)(6) 2018. Follow up scheduled for (b)(6) 2018. What prep was used prior to product application? hibiclens scrub and duraprep. What date did the reaction occur on? patients range from 1-6 weeks post-op before the rash is noticeable. Was there any medical or surgical intervention performed? hydrocortisone cream to be applied 2-3 times per day, benadryl tabs as needed, & ice the area.
 
Event Description
It was reported that a patient underwent a tibial orif procedure on (b)(6) 2018 and topical skin adhesive was used. Postoperatively, the patient was diagnosed with allergic contact dermatitis or skin infection. The patient was treated with cephalexin 250mg tid for ten days and triamcinolone 0. 1% bid for 2-3 weeks. The patient current condition is unknown. Additional information has been requested.
 
Manufacturer Narrative
Product complaint # (b)(4). Additional information was requested and the following was obtained: update to patient current condition : the patient¿s rash had resolved. No current issues or complaints.
 
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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
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 Key8035727
MDR Text Key126071306
Report Number2210968-2018-76916
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 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2018
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 Received11/05/2018
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: 11/02/2018 Patient Sequence Number: 1
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