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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 Wound Dehiscence (1154); Cellulitis (1768)
Event Date 04/03/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). 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. Does the surgeon believe that any of the ethicon products involved (prineo) caused and/or contributed to the post-operative complications (cellulitis of the incision requiring oral antibiotics and partial incision opening) described in the article? does the surgeon believe there was any deficiency with any of the ethicon products (prineo) used in this procedure? if so, please provide details. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. 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. The single complaint was reported with multiple events. There are no additional details regarding the additional events citation: citation cite: surgery 170 (2021) 939e941 https://doi. Org/10. 1016/j. Surg. 2021. 02. 057.
 
Event Description
Title: fat grafting: a novel technique for difficult ostomy management the goal of the surgical prep was to separate the stoma and peristomal skin from the operative area. Once the stoma was covered, the operative field was prepped using sterile technique, and the clinical contour areas of concern were marked on the patient before applying an antimicrobial. Patients referred by the enterostomal service between january 2015 and january 2019 were considered for this intervention. A total of 11 patients underwent parastomal acquired contour deformity in the study period. The median age was 48 years old. Before exposing the stoma at the end of the case, all incisions were sealed with liquid adhesive and self-adhering mesh (dermabond-prineo; ethicon, new brunswick, nj). Reported complications included skin excision patients developed cellulitis of the incision requiring oral antibiotics and partial incision opening (n
=
2). In conclusion, this represents the largest case series to date using fat grafting for correcting parastomal contour irregularities and highlights its safety and feasibility. Postprocedural ostomy care and skin abnormalities are improved up to at least 1 year. Fat grafting represents readily available and relatively inexpensive technique in the surgical armamentarium for the management of parastomal soft-tissue contour irregularities. It should be considered in such patients.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13053909
MDR Text Key288283230
Report Number2210968-2021-12825
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 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received11/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2021 Patient Sequence Number: 1
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