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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 Problems Unspecified Infection (1930); Impaired Healing (2378)
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 but unavailable: does the surgeon believe the ethicon prineo caused or contributed to delayed wound healing or infection? were the cases discussed in this article previously reported to ethicon? can specific patient demographics be provided for the subjects of this article? if so, please also include: patient initials, initial procedure date, pre-existing conditions, specific medical/surgical intervention per patient. Is the product code and lot number available for any of the ethicon devices used? do you have any photos? what is the physicians opinion of the contributing factors to the infection? are there devices available to be returned for analysis? citation: aesth plast surg (2013) 37:529¿537. Doi 10. 1007/s00266-013-0123-3.
 
Event Description
It was reported in journal article ¿use of 2-octyl cyanoacrylate together with a self-adhering mesh (dermabondtm prineotm) for skin closure following abdominoplasty: an open, prospective, controlled, randomized, clinical study¿ two methods of wound closure were evaluated after abdominoplasty. The purpose of this study was to perform a cost analysis of the two methods of wound closure for topical skin adhesive and suture and to evaluate the potential advantages of the topical skin adhesive. The authors prospectively studied the results of wound closure after abdominoplasty with randomized use of topical skin adhesive and conventional suturing to assess the possible difference in outcome between these 2 methods. Sixty patients [52 women, 8 men; mean age 43+/-12 (range 21-65) years; mean bmi 25. 7+/-3. 1 kg/m2] who were scheduled for abdominoplasty were included in the study. For the surgical procedure, after completion of abdominal dermolipectomy and closure of subcutaneous fat, the wound edges were approximated with interrupted, buried, resorbable intradermal sutures. For skin closure, patients were randomized to one of 2 groups. Group 2 (n
=
30) had cutaneous closure with topical skin adhesive. Complications noted on follow-up were purulent wound infection healed uneventfully with oral antibiotics and local care for 10 days and delayed wound healing. 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 08876 0151
Manufacturer (Section G)
ETHICON INC.
road 183, km. 8.3
san lorenzo
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7026338
MDR Text Key91898474
Report Number2210968-2017-71206
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 10/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR602
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 11/13/2017 Patient Sequence Number: 1
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