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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
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414); No Code Available (3191)
Event Date 02/17/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).Date sent to fda: 05/30/2017.(b)(4).This medwatch report is in response to receipt of maude event report #mw5069254.Attempts have been made to retrieve the device.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.
 
Event Description
It was reported that a patient underwent a wound closure procedure on an unknown date and topical skin adhesive was used.On (b)(6) 2017 the patient developed an acute dermatologic reaction and allergy.Blistering and skin loss occurred.The patient was treated with topical therapy.Additional information has been requested.
 
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Brand Name
PRINEO SKIN CLOSURE SYSTEM
Type of Device
SURGICAL 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 Key6600058
MDR Text Key76236042
Report Number2210968-2017-32336
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 05/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/12/2017
Initial Date FDA Received05/30/2017
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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