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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 Wound Dehiscence (1154)
Event Date 03/12/2019
Event Type  Injury  
Event Description
Title: outcome of direct anterior total hip arthroplasty complicated by superficial wound dehiscence requiring irrigation and debridement the purpose of this retrospective study from a prospectively collected, single-institution joint registry was to examine the clinical outcomes of total hip arthroplasty (tha) performed through the direct anterior approach (daa) that required postoperative superficial irrigation and debridement (i&d). A total of 1573 patients (799 male and 774 female; mean age of 64 (19-97) years; mean bmi of 30 (14-60) kg/m2) who underwent tha using daa between august 26, 2010 and july 11, 2018 were included in the study. Either steri-strips with an overlying layer of dermabond (ethicon, somerville, new jersey) or dermabond prineo (ethicon, somerville, new jersey) was placed on the skin surface. Reported complications include superficial wound dehiscence (n
=
18) requiring superficial irrigation and debridement (i&d) and additional intravenous antibiotics/oral antibiotics in the following patients: (b)(6) female patient. (b)(6) female patient. (b)(6) female patient. (b)(6) female patient. (b)(6) female patient. (b)(6) male patient. (b)(6) female patient. (b)(6) female patient. (b)(6) female patient. (b)(6) male patient. (b)(6) female patient. (b)(6) female patient. (b)(6) female patient. (b)(6) female patient. (b)(6) female patient. (b)(6) male patient. (b)(6) female patient. (b)(6) female patient. In conclusion, superficial wound dehiscence requiring superficial i&d after daa tha occurs in about 1%-2% of patients and is more common in female patients and those with higher bmis. Superficial i&d is an effective treatment option for wound dehiscence with a low risk for subsequent pji. Patients can be expected to be satisfied with their tha with high clinical outcomes scores. In high-risk patients undergoing daa tha, extra care should be taken to respect the soft tissues, and when appropriate, a different approach should be utilized to avoid this complication.
 
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 or dermabond) caused and/or contributed to the post-operative complications (wound dehiscence, medication required, surgical intervention) described in the article? does the surgeon believe there was any deficiency with any of the ethicon products ( prineo or dermabond) 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. Related events captured via mw# 2210968-2021-12763, mw# 2210968-2021-12764, mw# 2210968-2021-12765, mw# 2210968-2021-12766, mw# 2210968-2021-12767, mw# 2210968-2021-12768, mw# 2210968-2021-12769, mw# 2210968-2021-12770, mw# 2210968-2021-12771, mw# 2210968-2021-12772, mw# 2210968-2021-12773, mw# 2210968-2021-12774, mw# 2210968-2021-12775, mw# 2210968-2021-12776, mw# 2210968-2021-12777, mw# 2210968-2021-12778, mw# 2210968-2021-12779, mw# 2210968-2021-12780, mw# 2210968-2021-12781, mw# 2210968-2021-12782, mw# 2210968-2021-12785, mw# 2210968-2021-12786, mw# 2210968-2021-127857, mw# 2210968-2021-12788, mw# 2210968-2021-12789, mw# 2210968-2021-12790, mw# 2210968-2021-12791, mw# 2210968-2021-12792, mw# 2210968-2021-12793, mw# 2210968-2021-12794, mw# 2210968-2021-12795, mw# 2210968-2021-12796, mw# 2210968-2021-12797, mw# 2210968-2021-12798, mw# 2210968-2021-12800. Citation: the journal of arthroplasty (2019); 34:1492-1497. Https://doi. Org/10. 1016/j. Arth. 2019. 03. 020. 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 Key13049445
MDR Text Key288026823
Report Number2210968-2021-12799
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 12/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
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: 12/20/2021 Patient Sequence Number: 1
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