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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 01/01/2020
Event Type  Injury  
Event Description
Title: improving efficiency of hip fracture care by simplifying wound management and eliminating unnecessary clinical follow-up this retrospective study aims to evaluate how a change in practice to 2-octyl cyanoacrylate adhesive (dermabond®) with polyester mesh (prineo®) and elimination of the 2-week follow-up visit impacts quality and efficiency of care after hip fracture and determine the impact of simplified wound closure and extended clinical follow-up on the number of outpatient calls to nurses and wound complications. From january 1, 2017 to december 31, 2017 (prior to implementation of hip fracture wound management protocol) and january 1, 2018 to december 31, 2018 (after implementation of the protocol), two hundred eight patients who underwent surgical fixation or arthroplasty for hip fracture during a oneyear period immediately preceding and following the implementation of prineo® closure (hip arthroplasty - 41; cephalomedullary nail ¿ 81; sliding hip screw ¿ 20; cannulated screw ¿ 66) , aged
=
(b)(6) were identified and included in this assessment. Reported complication included: (n
=
4) superficial surgical site infection. (n
=
3) deep surgical site infection. It was concluded, that dermabond® prineo® closure system has previously been evaluated for a variety of procedures, its efficacy in terms of wound closure and patient impact has not been explicitly evaluated in geriatric patients with hip fractures. Importantly, the use of this closure system can eliminate the need for a 2-week follow-up, reducing the burden of care and cost. The findings of this study can potentially influence the practice of hip fracture operative care and reduce costs and burden of care while increasing patient satisfaction and quality of life. Considering the substantial increase in nationwide hip fractures and consequential morbidity and mortality, increasing effective treatment of hip fractures has potential to significantly impact quality of life and healthcare system costs for patients.
 
Manufacturer Narrative
Product complaint # (b)(4). Additional information: (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 (deep surgical site infection, 10 cases of readmission) 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: the iowa orthopedic journal volume 40 issue 1 147. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
Title: improving efficiency of hip fracture care by simplifying wound management and eliminating unnecessary clinical follow-up this retrospective study aims to evaluate how a change in practice to 2-octyl cyanoacrylate adhesive (dermabond®) with polyester mesh (prineo®) and elimination of the 2-week follow-up visit impacts quality and efficiency of care after hip fracture and determine the impact of simplified wound closure and extended clinical follow-up on the number of outpatient calls to nurses and wound complications. From january 1, 2017 to december 31, 2017 (prior to implementation of hip fracture wound management protocol) and january 1, 2018 to december 31, 2018 (after implementation of the protocol), two hundred eight patients who underwent surgical fixation or arthroplasty for hip fracture during a oneyear period immediately preceding and following the implementation of prineo® closure (hip arthroplasty - 41; cephalomedullary nail ¿ 81; sliding hip screw ¿ 20; cannulated screw ¿ 66) , aged
=
(b)(6) were identified and included in this assessment. Reported complication included: (n
=
4) superficial surgical site infection. (n
=
3) deep surgical site infection. It was concluded, that dermabond® prineo® closure system has previously been evaluated for a variety of procedures, its efficacy in terms of wound closure and patient impact has not been explicitly evaluated in geriatric patients with hip fractures. Importantly, the use of this closure system can eliminate the need for a 2-week follow-up, reducing the burden of care and cost. The findings of this study can potentially influence the practice of hip fracture operative care and reduce costs and burden of care while increasing patient satisfaction and quality of life. Considering the substantial increase in nationwide hip fractures and consequential morbidity and mortality, increasing effective treatment of hip fractures has potential to significantly impact quality of life and healthcare system costs for patients.
 
Manufacturer Narrative
Product complaint # (b)(4). Additional information: (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 (deep surgical site infection, 10 cases of readmission) 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: the iowa orthopedic journal volume 40 issue 1 147. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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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 Key13053600
MDR Text Key285932646
Report Number2210968-2021-12821
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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