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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 Problems Unspecified Infection (1930); Seroma (2069)
Event Type  Injury  
Manufacturer Narrative
(b)(4). This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. 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. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: pleura and peritoneum. 2018; 1, special suppl; sa6¿sa463. Doi: https://doi. Org/10. 1515/pap-2018-7016. (b)(4).
 
Event Description
It was reported via a journal article "title: bundled care to reduce surgical site infections after cytoreductive surgery and hipec". Authors: e. Poli, m. Millis, s. Sherman, f. Dahdaleh, a. Kamm, k. Turaga. Citation: pleura and peritoneum. 2018; 1, special suppl; sa6¿sa463. Doi: https://doi. Org/10. 1515/pap-2018-7016. Cytoreductive surgery (crs) and hyperthermic intraperitoneal chemotherapy (hipec) has been reported to have a high incidence (16%) of superficial and deep surgical site infections (ssi). The authors implemented an ssi bundle after inception of a regional therapies program in 2016. A total of 51 patients (mean age: 57. 3 years) were included in the study. During the surgical procedure, wound closure was augmented with the dermabond prineo system (ethicon). Reported complications included suspected infection (n-4) which required 2 doses of antibiotics and superficial surgical site infection and seroma (n-1) which required 2 doses of antibiotics. Bundled care and systematic practices established at the inception of a regional therapies program at a large tertiary university hospital resulted in a low rate of surgical site infections. Translation of ssi reduction bundles from other surgical procedures appears feasible in patients undergoing crs and hipec.
 
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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
982 road 183 km 8.3
san lorenzo
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8994113
MDR Text Key158880224
Report Number2210968-2019-87007
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 literature
Reporter Occupation
Type of Report Initial
Report Date 08/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2019
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 Received08/15/2019
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: 09/11/2019 Patient Sequence Number: 1
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