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U.S. Department of Health and Human Services

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

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ETHICON INC. DERMABOND PRINEO SURGICAL SEALANT Back to Search Results
Catalog Number CLR222
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Reaction (2414)
Event Date 07/25/2017
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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Please provide photos what is the physicians opinion of the contributing factors to the reaction? do you have the lot number involved is a representative sample (product from the same lot number) available for evaluation?.
 
Event Description
It was reported that a patient underwent a total knee replacement procedure on (b)(6) 2017 and topical skin adhesive was used. The topical skin adhesive was placed over the incision and covered with primapore. The primapore was changed post op day one. A rash was first noticed on (b)(6) 2017. Primapore was removed on (b)(6) 2017 and a fresh one was put on later that day. The patient was discharged to rehab on (b)(6) 2017. On (b)(6) 2017 the rehab unit called saying rash was worse. They were told to remove the topical skin adhesive. The patient was started on keflex, zyrtec, and zantac. The patient was seen on (b)(6) 2017. The patient was prescribed benadryl 25 mg every 6 hours and 1% hydrocortisone cream on the rash (but not on incision). During a follow up visit on (b)(6) 2017, it was noted the patient's rash went away after four days of prednisone, zantac, and zyrtec, and keflex. The rash is now completely gone. It was noted that the patient has an allergy to adhesives and latex. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON INC. SAN LORENZO
road 183, km. 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key6845865
MDR Text Key85010201
Report Number2210968-2017-70202
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 Physician Assistant
Type of Report Initial
Report Date 08/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/09/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/06/2017 Patient Sequence Number: 1
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