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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); Post Operative Wound Infection (2446)
Event Date 08/27/2020
Event Type  Injury  
Manufacturer Narrative
(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 (infection, wound complications and surgical site infection) 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 cite: s. S. Johnston et al. / the spine journal 21 (2021) 45-54. Https://doi. Org/10. 1016/j. Spinee. 2020. 08. 017.
 
Event Description
Title: economic and clinical outcomes of spinal fusion surgeries with skin closure through skin staples plus waterproof wound dressings versus 2-octyl cyanoacrylate plus polymer mesh tape the purpose of this study is to compare the economic and clinical outcomes of spinal fusion surgeries using one of two sutureless skin closure techniques: skin staples plus waterproof wound dressings (sswwd) or 2-octyl cyanoacrylate plus polymer mesh tape (2opmt). A total of 11,991 patients met the study criteria and underwent spinal fusion surgery for a spine disorder between october 1, 2015 and march 31, 2019. 2-octyl cyanoacrylate [dermabond ; ethicon inc, nj, usa]) was used. Reported complications included lower rate of infections, wound complications and surgical site infection. In conclusion in this retrospective observational study of patients undergoing elective inpatient spinal fusion surgery, the use of 2opmt for skin closure was associated with significantly lower ort, los, non-home discharge, and 90-day rates of infections/wound complications as compared with sswwd.
 
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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 Key13054494
MDR Text Key288170643
Report Number2210968-2021-12833
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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