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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 Patient-Device Incompatibility (2682)
Patient Problems Hypersensitivity/Allergic reaction (1907); Skin Irritation (2076); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). (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. If further details are received at a later date a supplemental medwatch will be sent. What does the reaction look like and how large of an area does the reaction cover? do you have any pictures of the reaction? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify: removal of dermabond 1 week post-op. What is the most current patient status? can you identify the lot number of the product that was used? was the resolve topical cream prescribed or over the counter? prescribed.
 
Event Description
It was reported that a female patient underwent open reduction internal fixation fracture tibial plateau procedure on (b)(6) 2018, and topical skin adhesive was used. The patient developed a skin reaction two days post op from the topical skin adhesive. The topical skin adhesive was removed one week post op in the surgeons room. The patients current condition is fine, they were treated with resolve topical cream and an antihistamine. The patient had a clear honeycomb opsite dressing over the top of the topical skin adhesive. Additional information has been 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
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 Key8127305
MDR Text Key129191553
Report Number2210968-2018-77465
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeAU
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 11/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2018
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: 12/03/2018 Patient Sequence Number: 1
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