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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 Problems Rash (2033); Skin Irritation (2076)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional information was requested and the following was obtained: did the patient experience a post-op device malfunction? no. Did the patient experience an adverse event? yes. Did the patient require revision surgery or hardware removal? no. If no, was there any additional medical intervention required? removal of prineo and local steroids. Patient status/ outcome / consequences yes. Patient consequence description/was there a clinical outcome experienced by the patient? reported skin reaction. Was other medical intervention required: yes. If yes, describe steroid cream. Photos available? no. Can you confirm date/approx. How long did the reaction occur post op? noted approx. 8-10 days post op. What prep was used prior to, during or after prineo use? chlorhexidine. Was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? not that dr was aware. Were any patch or sensitivity tests performed? no. What is the physician¿s opinion of the contributing factors to the reaction? allergic chemical reaction to the product. Patient demographics: initials / id; age or date of birth; bmi; gender ¿ will try to obtain. Patient pre-existing medical conditions (ie. Allergies, history of reactions) - will try to obtain. For female patients ask: was the patient exposed to similar products, such as artificial nails? no. Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown. What is the most current patient status? rash has settled. Dr also reported patient now approximately 3 weeks post operation, but could not recall on the phone the day of the procedure. He also noted that the patient was likely to have been operated on at different hospital but couldn't be sure. 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 total knee replacement on an unknown date in (b)(6) 2019 and topical skin adhesive was used. A skin reaction was noted approximately 8-10 days post operation. It was treated with removal of adhesive and a local steroid cream. The most current patient status noted that rash has settled.
 
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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 Key8437338
MDR Text Key139353198
Report Number2210968-2019-79580
Device Sequence Number1
Product Code OMD
UDI-Device Identifier10705031237339
UDI-Public10705031237339
Combination Product (y/n)N
Reporter Country CodeAS
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 02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2019
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 Received02/25/2019
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: 03/20/2019 Patient Sequence Number: 1
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