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U.S. Department of Health and Human Services

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

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ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 06/13/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). The following information was requested, however not obtained to date: patient symptoms manifestations (location, severity, appearance, systemic or local reaction)? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? please describe how was the adhesive was applied on the tape what prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? do you have the product code and/or lot number involved? what is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient pre-existing medical conditions (ie. Allergies, history of reactions) was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? 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 a patient underwent a knee replacement surgery on (b)(6) 2019 and topical skin adhesive was used. Two weeks postop, (b)(6) 2019 adhesive was removed by doctor. The patient had a surgical site infection. At that time a small amount of drainage was noted at the distal end of the incision. The wound was cleaned with betadine and dressed with a 4 x 4. 6/17 culture positive for enterobacter cloacae and keflex started. (b)(6) patient underwent ¿washout¿ at a different hospital. Femoral and synovial cultures were negative. Additional information was requested.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
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
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8916588
MDR Text Key155084398
Report Number2210968-2019-85949
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2019
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

Patient Treatment Data
Date Received: 08/21/2019 Patient Sequence Number: 1
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