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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 22CM SURGICAL SEALANT Back to Search Results
Catalog Number CLR222
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Seroma (2069); Not Applicable (3189)
Event Date 06/11/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. 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. Please explain what was the findings at the re-operation? initial procedure date. How was the patient treated when the prineo was removed? date that patient was brought back for re-suturing? reason that patient was brought back for re-suturing? is the event related to wound dehiscence? how was the seroma treated? please indicate what medical or surgical interventions were performed? what is the physicians opinion of the contributing factors to the event? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender. Patient pre-existing medical conditions. Additional information was requested and the following was obtained: this error occurred due to an absence of ward nurse education. They were a new user of the product.
 
Event Description
It was reported that a patient underwent a knee surgery on an unknown date and topical skin adhesive was used. Post operatively, the topical skin adhesive was inadvertently removed after only 2 days. The nurse reports that there appeared to a substantial seroma formation under the topical skin adhesive. The patient returned to the operating theater to have the knee re-sutured subcuticularly with continuous technique. Additional information has been requested.
 
Manufacturer Narrative
Product complaint # pc-(b)(4). Date sent to fda: (b)(4) 2018. Additional information was requested and the following was obtained: what is the physicians opinion of the contributing factors to the event? the doctor does not have any issues with prineo. He is looking to continue evaluating the product. The doctor was disappointed with the ward nurse not being familiar with the post op management of the product. Also, the floor co-ordinator wasn¿t familiar and gave incorrect advice to remove the product. This was the issue. Training has been provided to ensure that all new team members are captured and competent in their awareness of prineo¿s capability.
 
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Brand NameDERMABOND PRINEO 22CM
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO
982 road 183 km 8.3
san lorenzo PR
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7710417
MDR Text Key114710010
Report Number2210968-2018-74543
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222
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 Received08/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/23/2018 Patient Sequence Number: 1
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