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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 Necrosis (1971); Post Operative Wound Infection (2446); Insufficient Information (4580)
Event Date 12/22/2020
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. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation: https://doi. Org/10. 1016/j. Bjps. 2020. 12. 095. 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 (vicryl mesh and prineo skin closure system) 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 involved? patient demographics? event related to prineo skin closure system product. Event related to vicryl mesh product reported via mw # 2210968-2021-12751.
 
Event Description
It was reported in a journal article with title: setting up a new microsurgical breast service in a non-tertiary hospital: is it safe, and do outcomes compare to centres of excellence? the aim of the study was to show how a new microsurgical service could be established in a non-major teaching hospital and to compare our outcomes to microsurgical centers that employ an enhanced recovery protocol. From july 2018-july 2020, a total of 40 patients undergoing deep inferior epigastric perforator (diep) reconstruction were included. Of these, 70% were immediate, mean age was 49 years (27¿68) and bmi was 28. 1 kg/m2 (22¿32. 5). In all, 50% had one or more co-morbidities other than breast cancer. All flaps were performed by a single team consisting of the senior author and a plastic surgery trainee/resident (grade st3-st8). The diep flap was harvested using the sos technique. All flaps were based on a single perforator, identified from preoperative ct angiography, with no muscle sacrifice (ms-3). No contralateral surgery was performed concomitantly. Donor closure was performed by central undermining of the abdominal flap, with excision of the sub-scarpa fat. A vicryl mesh (ethicon, inc. , somerville, nj) was placed retrorectus followed by rectus fascia closure. Progressive tension sutures of the abdominal flap were performed and no abdominal drains were employed. Wounds were dressed using the dermabond, prineo skin closure system (ethicon, inc. , somerville nj). Reported postoperative complications included n
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3 flap salvage, n
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4 wound infection, n
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6 mastectomy necrosis, n
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6 fat necrosis, n
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7 clavien-dindo i complications, n
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2 clavien-dindo ii complications and n
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12 clavien dindo iiib complications. In conclusion, using an enhanced recovery protocol and careful patient selection can achieve surgical- and patient-reported outcomes comparable with international high volume centers almost immediately.
 
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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
982 road 183 km 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13052819
MDR Text Key288184234
Report Number2210968-2021-12750
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study,Literature,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/24/2022
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
Is the Reporter a Health Professional? No
Date Manufacturer Received12/29/2021
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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