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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM -US SURGICAL SEALANT

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ETHICON INC. PRINEO SKIN CLOSURE SYSTEM -US SURGICAL SEALANT Back to Search Results
Catalog Number CLR602US
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Scarring (2061)
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? name of procedure? what is meant by permanent scarring? what date did the reaction occur post op? 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? were any patch or sensitivity tests performed? what is the physicians opinion of the contributing factors to the reaction? patient demographics: initials / id; age or date of birth; bmi ; gender patient pre-existing medical conditions (ie. Allergies, history of reactions) for female patients ask: was the patient exposed to similar products, such as artificial nails?.
 
Event Description
It was reported that the patient underwent a plastic surgery procedure on an unknown date and topical skin adhesive was used. The patient returned with an allergic reaction where the topical skin adhesive was applied. The doctor may have removed the topical skin adhesive and applied topical steroids. It is possible that the patient may have permanent scarring from the topical skin adhesive. Additional information has been requested.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM -US
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 Key7596352
MDR Text Key110910120
Report Number2210968-2018-73445
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082289
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 05/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR602US
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 Received05/18/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/13/2018 Patient Sequence Number: 1
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