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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Skin Irritation (2076)
Event Date 05/03/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional information was requested and the following was obtained: please indicate any medical or surgical interventions performed. Hydrocortisone prescribed. Please describe how was the adhesive was applied on the tape. One layer application. What prep was used prior to, during or after prineo use? n/a. Was a dressing placed over the incision? if so, what type of cover dressing used? no. 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? no. It was noted a quantity of 2 was used on the patient, please verify that 2 products of prineo 22 were actually used? yes. Do you have the lot number involved? no. What is the physicians opinion of the contributing factors to the reaction? sensitive skin. What is the most current patient status? discharged. 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: female patient. Others not available. Patient pre-existing medical conditions (ie. Allergies, history of reactions) unknown. Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? no. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported a patient underwent a right diep flap procedure on (b)(6) 2019 and topical skin adhesive was used. On post op day 4, (b)(6) 2019 the patient developed redness, allergic reaction around adhesive application site. The adhesive was removed and hydrocortisone prescribed. Additional information was requested.
 
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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 PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8662393
MDR Text Key146790759
Report Number2210968-2019-82246
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeSN
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
Report Date 05/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2019
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2019
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: 06/03/2019 Patient Sequence Number: 1
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