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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 Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033); Skin Irritation (2076); No Code Available (3191)
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: what was the name of the procedure? -total knee or total hip please describe how was the adhesive applied on the tape? - technique applied says she used about a quarter of the liquid and sometime she would rub/ spread it in with her finger. Is the patient hypersensitive to pressure sensitive adhesives?-unknown. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? - no. Were any patch or sensitivity tests performed? - they do not do that. Do you have the lot number involved? -no. What is the physicians opinion of the contributing factors to the rash/ blister? - unknown. Patient demographics: initials / id; age or date of birth; bmi; gender? - no. Patient pre-existing medical conditions (ie. Allergies, history of reactions)? -no. What is the most current patient status? patient may have been seen at their 6 week appointment and it was cleared up. Is the product or representative sample (product from the same lot number) available for evaluation? -no.
 
Event Description
It was reported that a patient underwent a total knee or total hip surgery on an unknown date and topical skin adhesive was used. The patient had a sensitivity issue with the topical skin adhesive and had a rash and some blistering. The patient may have been sent to dermatology. The reaction occurred within the first two weeks post op of surgery. The patient was prescribed benadryl and a steroid creme for topical use. The facility is no longer using the topical skin adhesive. The patient may have had the topical skin adhesive used on both sides of their body, at different times. The first time for one leg with no reaction and then the following procedure for the other leg there is a reaction to the topical skin adhesive. When the topical skin adhesive is put on they flex the knee. The skin is prepped prior to incision with chlorapep and the drape is ioban on the knee and that is washed off prior to topical skin adhesive application. After surgery when the topical skin adhesive is dry cast padding and then an ace wrap for knee is used. Additional information has been requested.
 
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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 Key8127494
MDR Text Key129148514
Report Number2210968-2018-77467
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
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2018
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: 12/03/2018 Patient Sequence Number: 1
Treatment
CHLORAPREP, IOBAN
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