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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT Back to Search Results
Model Number CLR222US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Not Applicable (3189)
Event Date 07/25/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). The following information was requested and obtained. If the further details are received at a later date a supplemental medwatch will be sent. Date of surgery? (b)(6) 2020. Date of wound dehiscence/surgical intervention? (b)(6) 2020. Was there any other treatment provided (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed) ? if so, please clarify. Once wound dehiscence was noted a mepilex was placed over the prineo dressing and the patient was scheduled for a wound irrigation and debridement with closure on the evening of (b)(6) 2020. Please indicate specific medical or surgical interventions performed. Original surgery was a primary total knee arthroplasty, second surgery performed was an irrigation and debridement with closure, as a result of the wound dehiscence were any anomalies/damage noted with the product prior to use? none reported. Please describe how was the adhesive was applied. On a dry, hemostatic surface, in flexed position, after closure of capsule, subcutaneous, and subcuticular layers. What prep was used prior to, during or after prineo use? chloraprep as surgical prep (but was wiped with saline lap and dried off). Was a dressing placed over the incision? if so, what type of cover dressing used? dry gauze-abd pads and ace wrap were placed over dressing in the operating room, floor nurse placed mepilex over dressing when wound dehiscence was noted. What is the physicians opinion of the contributing factors to the wound dehiscence? the surgeon felt like maybe the patient might have had a partial fall or done something to cause increased stress to the sutures to cause a dehiscence. He felt his closure was strong and was surprised that it had come apart. What is the most current patient status? unknown at this time. Is the product lot number available? qcbhjh. Patient demographics: initials / id - (b)(6); age or date of birth-(b)(6); gender-f; bmi-26. 33. Was there any patient precipitating factors that lead to the wound dehiscence (ex. Fall, strenuous exercise, etc. )? nothing that was noted, surgeon did question if something had happened that would have caused extra stress on the sutures. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
It was reported a patient underwent a total knee arthroplasty on (b)(6) 2020 and surgical sealant was used. Post operatively, the wound dehisced. The patient had a second surgery performed, irrigation and debridement with closure, as a result of the wound dehiscence no other information is available. No device will be returned. Additional information requested.
 
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Brand NameDERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10412052
MDR Text Key205677864
Report Number2210968-2020-06149
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model NumberCLR222US
Device Catalogue NumberCLR222US
Device Lot NumberQCBHJH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/17/2020 Patient Sequence Number: 1
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