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U.S. Department of Health and Human Services

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

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ETHICON INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT Back to Search Results
Catalog Number CLR222US
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Rash (2033); Reaction (2414); No Code Available (3191)
Event Date 01/30/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Additional information was requested and the following was obtained: what was the specific location of the rash on the body. All 4 patient had reactions inside of both arms and inner thighs, and some patients also had across waist at back. Does the reaction extend 1-2 inches beyond each tape or only 1 site of the tape. Multiple areas. Rash was under arms, inner thighs, across back at waist. Rash was not systemic, rash was localized around tape. Were each of the 4 patients female and approximately 40 ¿ yes. Was the topical steroid cream prescribed or over the counter? treated with prescription topical steroids. Event dates: all 4 procedure dates were within the last quarter. No photos or patient demographic data is available. Please clarify "cut the skin away" mean - these are plastic surgery procedures. He uses a scalpel and scissors. The cases are big body lifts, removing a lot of skin.
 
Event Description
It was reported that the patient underwent a major body lift plastic procedure on unknown date and the topical skin adhesive was used. Following the procedure, the patient developed a rash and reaction was located inside of both arms and inner thighs, and/or across waist at back. Rash was not systemic but localized around tape. The patient was treated with prescription topical steroids.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM
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 PR
982 road 183 km 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
route 22 west po box 151
somerville, NJ 08876
9082182792
MDR Report Key6372456
MDR Text Key68816915
Report Number2210968-2017-30945
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 02/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2017
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 Received02/08/2017
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/02/2017 Patient Sequence Number: 1
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