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U.S. Department of Health and Human Services

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

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ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT Back to Search Results
Catalog Number CLR222US
Device Problem Material Integrity Problem (2978)
Patient Problems Wound Dehiscence (1154); Fever (1858); Unspecified Infection (1930); Not Applicable (3189); No Code Available (3191)
Event Date 06/13/2018
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. What tissue layer was each suture used? what is meant by the suture line appears to be compromised? what product had the suture line compromised? results of culture taken? what bacteria were identified? what medical or surgical interventions were performed? what prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? what is the physicians opinion of the contributing factors to the event? what is the most current patient status? lot number of sutures and prineo involved 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.
 
Event Description
It was reported that a patient underwent a revision total knee arthroscopy poly swap procedure on (b)(6) 2018 and topical skin adhesive was used to close the incision. The patient reported clear and yellow drainage through (b)(6) 2018. The patient returned to office and the physician assistant noticed edges still everted, slightly red and some yellow and clear drainage. On (b)(6) 2018, the patient went on a walk and the knee felt the best in two years. That same day, the patient came down with a fever of 102 degrees and knee became very stiff. Evaluated medications and the fever broke with ibuprofen. On (b)(6) 2018, the patient returned for a knee washout and cultures. The culture was taken from the skin all the way through joint capsule. The doctor opened the knee and noticed a soupy appearance and suture line appeared to be compromised. The patient had a normal weight and no additional co-morbidities. Additional information has been requested.
 
Manufacturer Narrative
Product complaint #
==
> pc-000215055 date sent to fda: 8/2/2018 additional information: 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. Additional information was requested and the following was obtained: what tissue layer was each suture used? stratafix symmetric suture, vicryl suture, spiral monocryl and dermabond prineo were used to close the incision. What is meant by the suture line appears to be compromised? all layers dehisced what product had the suture line compromised? failure at all levels results of culture taken? what bacteria were identified? enterococcus what medical or surgical interventions were performed? iv antibiotics / i & d with poly swap / two wash outs what prep was used prior to, during or after prineo use? cleansed with saline and dried prior to application was a dressing placed over the incision? if so, what type of cover dressing used? sterile 4x4 gauze, sterile waffle roll, and sterile double ace wrap what is the physicians opinion of the contributing factors to the event? hospital has been having issues with high infection rates, have not had this issue at the other location they go to / wife has ibs-d potential for patients¿ skin to be colonized with bacteria what is the most current patient status? (b)(6) ¿ cancelled appointments (b)(6) ¿ nothing since last i&d ¿ refused last home health appointment lot number of sutures and prineo involved ¿ n/a patient demographics: initials / id; age or date of birth; bmi ; gender: male (55 years old) / bmi 25. 9 patient pre-existing medical conditions: hypertension + high cholesterol.
 
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Brand NameDERMABOND PRINEO 22CM SKIN CLOSURE
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
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7652898
MDR Text Key112845181
Report Number2210968-2018-73950
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
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 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2018
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/29/2018 Patient Sequence Number: 1
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