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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 Appropriate Term/Code Not Available (3191)
Patient Problem Reaction (2414)
Event Date 01/17/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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. Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. The photo was reviewed and looks like product used was prineo.
 
Event Description
It was reported that the patient underwent a knee arthroplasty procedure on unknown date and the topical skin adhesive was used. After the procedure, the patient was released home and experienced a skin reaction. Additional information has been requested.
 
Manufacturer Narrative
The actual device batch number associated with this event is not known. The international affiliate reports the following four possible batch numbers: batch# kge884 exp date: 05/01/2018, mfr date: 06/22/2016, batch# kee637, batch#kjq227, batch # kke647. In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria. All representative samples were received. The devices evaluated for chemical analysis and performance during use applying the set time and set temperature analysis demonstrates that all devices perform per their intended design.
 
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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 Key6298405
MDR Text Key66430273
Report Number2210968-2017-30576
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR602
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/09/2017
Was Device Evaluated by Manufacturer? Yes
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: 02/02/2017 Patient Sequence Number: 1
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