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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); No Code Available (3191)
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: do you have any pictures? -unk. Procedure name -unk. Indication for initial surgery -unk. Initial procedure date -unk. Location and incision size of product application? -unk. What prep was used prior to prineo use? -unk. Please describe how the adhesive was applied on the tape? -unk. Was incision re-prepped before closure? if so, with what? -unk. Was a dressing placed over the incision? if so, what type of cover dressing used? -unk. Please explain how the skin was closed? -unk. For knee surgery ask what was the angle of the knee during application? -unk. Please describe any medical or surgical interventions performed -> apply ointment. What is the most current patient status? - good. Is the product or representative sample (product from the same lot number) available for evaluation?-unk. Patient demographics: initials / id; age or date of birth; bmi ; gender-unk. Patient pre-existing medical conditions -unk.
 
Event Description
It was reported that a patient underwent an orthopedic procedure on an unknown date and topical skin adhesive was used. The patient developed a rash from the topical skin adhesive. Ointment was applied and the patient recovered. The patient current status is good. Additional information has been requested.
 
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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 Key6538992
MDR Text Key74252423
Report Number2210968-2017-31910
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
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 Received04/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/02/2017 Patient Sequence Number: 1
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