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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 CLR602
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); No Code Available (3191)
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: 1. What is the procedure name and initial procedure date? -ulna nerve decompression and translocation - (b)(6) 2017. 2. What date did the reaction occur on? -within first 3-5 days. 3. What does the reaction look like and how large of an area does the reaction cover? -please see picture - it was swollen, red and bubbly - blisters. 4. Do you have any pictures of the reaction? -yes. 5. Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify. -silver nitrate cream and hydrocortisone cream. 6. What is the most current patient status? -patient says that area of incision or operation site is very sensitive still. 7. Can you identify the product code and lot number of the product that was used? -prineo - code not known, lot unknown.
 
Event Description
It was reported that a patient underwent a post-ulnar nerve decompression and translocation procedure on an (b)(6) 2017 and topical skin adhesive was used. Within 3-5 days post operatively, the patient experienced an allergic reaction to the topical skin adhesive. The patient was treated with silver nitrate cream and hydrocortisone cream. The area of the incision or operation site remains very sensitive. Additional information has been requested.
 
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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 Key8124762
MDR Text Key129065445
Report Number2210968-2018-77448
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR602
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2018
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

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