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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT

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ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Blister (4537); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Event Date 10/01/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional information has been requested and received. What is the procedure date? (b)(6) 2021. Can you please clarify what was the quality issue experienced with dermabond prineo product? my knee gradually swelled and the swelling extended down to my ankle and to my upper thigh. Did you have an adverse event or skin reaction to the product? the swelling was so bad that my skin got very hot and it was hypersensitive to touch. I developed several blisters around the incision site. This surgery as to be a single overnight stay in hospital but due to reaction to dermabond, i remained in hospital for 4 nights. If yes, was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify. Blood work to rule out infection. An ultrasound to rule out blood clots. I was given additional pain medication every 2 hours to control my pain. The adhesive closure was removed on (b)(6). If medication was required, please clarify if it was prescribed by a physician. I was still in hospital so yes it was prescribed by a physician have you been exposed to prineo/dermabond or other skin adhesives on a previous surgery or wound closure? no. This is my first exposure to dermabond. Additional information has been requested however not received. If further details are received at a later date a supplemental medwatch will be sent. Are photos available of the reaction? if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? no product is available for returned. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
It was reported a patient underwent a knee replacement on (b)(6) 2021 and topical skin adhesive was used. Patient's knee gradually swelled and the swelling extended down to ankle and to upper thigh. Swelling and skin got very hot and it was hypersensitive to touch, developed several blisters around the incision site. Surgery was to be a single overnight stay in hospital but due to reaction to adhesive,, patient remained in hospital for 4 nights. Blood work to rule out infection and given additional pain medication every 2 hours to control pain. The adhesive closure was removed on (b)(6) 2021. Additional information has been requested.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12868505
MDR Text Key281200446
Report Number2210968-2021-12044
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/24/2021 Patient Sequence Number: 1
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