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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 Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 01/09/2019
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. Additional information was requested and the following was obtained: did the wound dehisce? no. Did the prineo come off prematurely? yes. Was there any medical or surgical intervention performed? reclosure with application of a wound vac. What is the most current patient status? stable. Can you identify the lot number of the product that was used? n/a. Location and incision size of product application? n/a. What prep was used prior to prineo use? prineo was applied to dry wound edges at the conclusion of the case after a dermal closure was performed with a 2-0 vicryl. A single layer of prineo was applied. Please describe how the adhesive was applied on the tape? n/a. Was incision re-prepped before closure? if so, with what? n/a. Was a dressing placed over the incision? if so, what type of cover dressing used? n/a. What is the appearance of drainage (clear, purulent, serous)? n/a. Type of skin preparation used? n/a. Physicians opinion of the factors contributing to the event? ¿i am very concerned about this failure of the technology. I anticipated that the technology may fail in draining wounds, as the drainage could build up under the mesh and cause disruption of the bond between the mesh and the skin surface. ¿.
 
Event Description
It was reported that a (b)(6) year old female underwent a primary posterior cervical fusion procedure and topical skin adhesive was used. The topical skin adhesive was applied to the dry wound edges at the conclusion of the case after a dermal closure was performed with suture. A single layer of topical skin adhesive was applied. The woman¿s drain was removed, prior to that she had no drainage and once the sub fascial drain was removed there was some seepage through the incision. When the wound was checked on pod2, the topical skin adhesive was noted to have pulled off of the wound edges. The patient underwent reclosure and wound vac was applied to the incision. The surgeon anticipated that the technology may fail in draining wounds, as the drainage could build up under the mesh and cause disruption of the bond between the mesh and the skin surface. The patient current status is stable. Additional information was requested.
 
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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
road 183, km. 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8283945
MDR Text Key134402448
Report Number2210968-2019-78605
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
Report Date 01/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2019
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2019
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: 01/28/2019 Patient Sequence Number: 1
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