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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 Problems Not Applicable (3189); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Product complaint # pc-000083285 additional information was requested and the following was obtained: the doctor reported that the procedure was performed with 60 degree knee flexion and an aggressive motion protocol was used. It was also reported that the patient may have required debridement.
 
Manufacturer Narrative
Product complaint #
==
> pc-000083285 additional information was requested and the following was obtained: initial procedure date: unknown what was the angle of the knee during application? full flexion please describe how was the adhesive applied on the tape 1 coating what prep was used prior to, during or after prineo use? duraprep and ioban was a dressing placed over the incision? if so, what type of cover dressing used? no was there any infection reported? no if yes, was the site cultured? if so, what bacteria were identified? please provide photos (if not provided) photos already provided is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown is the patient hypersensitive to pressure sensitive adhesives? unknown were any patch or sensitivity tests performed? unknown do you have the lot number involved ? no what is the physicians opinion of the contributing factors to the event? surgeon thinks it¿s a mechanical issue with the tape what is the most current patient status? unknown is the product or representative sample (product from the same lot number) available for evaluation? no patient demographics: initials / id; age or date of birth; bmi ; gender unknown patient pre-existing medical conditions (ie. Allergies, history of reactions) unknown for female patients ask: was the patient exposed to similar products, such as artificial nails was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?unknown.
 
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. Initial procedure date? what was the angle of the knee during application? please describe how was the adhesive applied on the tape? 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? was there any infection reported? if yes, was the site cultured? if so, what bacteria were identified? please provide photos (if not provided). Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? do you have the lot number involved ? 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 (ie. Allergies, history of reactions)? for female patients ask: was the patient exposed to similar products, such as artificial nails? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.
 
Event Description
It was reported that a patient underwent a knee surgery on an unknown date and topical skin adhesive was used. The skin adhesive was placed over the knee incision. Skin blister developed around the topical skin adhesive dressing on post-op days 2-4. The patient was seen in office where physician assistant aspirated fluid from blister with a needle. The patients blister was then treated with silvadene. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO 22CM SKIN CLOSURE
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC
route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR 00754
Manufacturer Contact
darlene kyle
route 22 west
somerville, NJ 08876
9082182792
MDR Report Key7139325
MDR Text Key106728031
Report Number2210968-2017-71898
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,Followup
Report Date 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/21/2017 Patient Sequence Number: 1
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