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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 Compatibility Problem (2960)
Patient Problems Pain (1994); 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: how was the device applied to the incision ¿ proximal to distal, uses 2 prineo and overlap by ½¿ ¿ second one is used because of the hyperflexing; no tension; lets dry, wraps knee what prep was used prior to product application? unknown. Was a dressing placed over the incision? if so, what type of cover dressing used? sometimes 2 x 4. Please explain how the skin layers were closed to reduce skin tension? capsule is closed with interrupted 1-0, 2-0 vicryl suture; skin 3-0 monocryl to close dermis can you identify the lot number of the product that was used? unknown. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown. What is the most current patient status? patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i. E. Allergies, history of reactions) : unknown - full spectrum of patients. Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.
 
Event Description
It was reported that a patient underwent a total knee procedure on an unknown date and topical skin adhesive was used. The topical skin adhesive was applied to the skin on knee in full flexion. Approximately two weeks post op, the patient had painful blisters and rash. Some blisters had also popped. The patient may have been treated with oral antibiotics or topical antibiotic ointment. 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 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7697044
MDR Text Key114288766
Report Number2210968-2018-74467
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
Reporter Occupation
Type of Report Initial
Report Date 06/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
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 Received06/27/2018
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: 07/17/2018 Patient Sequence Number: 1
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