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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 Compatibility Problem (2960)
Patient Problems Not Applicable (3189); No Code Available (3191)
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 do you have any photos? what was the angle of the knee during application? was tension reviewed before applying the mesh? procedure date that blistering was noticed? what prep was used prior to prineo use? please describe how the adhesive was applied on the tape? was the dermabond liquid adhesive placed to cover the entire length of the mesh? did the prineo mesh extend beyond the patient incision? was incision re-prepped before closure? if so, with what? if so, was the prep allowed to dry? was the skin prep solution wiped off and allowed to dry before applying adhesive? was a dressing placed over the incision? if so, what type of cover dressing used? what does the reaction look like? please provide details. What type of medication? dose? when (date) administered? was the product removed? was another method used to close the incision? is the patient hypersensitive to pressure sensitive adhesives? lot number involved what is the physicians opinion of the contributing factors to the blistering ? 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.
 
Event Description
It was reported that a patient underwent a knee arthroplasty procedure and topical skin adhesive was used. Post operatively the patient presented with blisters below the knee in the upper shin area. Blisters were the size of 10 cent pieces and were drained by needle aspiration. Additional information has been requested.
 
Manufacturer Narrative
Product complaint #
==
> (b)(4). Additional information received that indicates this event does not meet reporting serious injury criteria. This event therefore is not reportable. Corrected patient codes: (b)(4). - blistering additional information was requested and the following was obtained: the blisters were small pimple like blisters at the distal tip of the mesh below the knee. The patients blisters did not require drainage. The patient did not have infection. It is unknown if the patient had any allergies. Do you have any photos? no. What type of medication? none required. Is the product or representative sample (product from the same lot number) available for evaluation? no.
 
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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 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7730178
MDR Text Key115351243
Report Number2210968-2018-74713
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeNZ
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 07/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2018
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 Received08/02/2018
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/29/2018 Patient Sequence Number: 1
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