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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 Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Local Reaction (2035)
Event Date 05/15/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional information has been requested however not received. If further details are received at a later date a supplemental medwatch will be sent please obtain consent and provide photos. Please clarify the extent of the patient¿s skin reaction. What was the date of the reaction or day post op? what other medical and or surgical intervention was provided to address the issue? please describe how was the adhesive was applied. 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? 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? if yes, results available? patient demographics: id, age or date of birth; bmi has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? current patient status. No product is available for return.
 
Event Description
It was reported a patient underwent a total knee replacement on (b)(6) 2021 and topical skin adhesive was used. The patient had a severe allergic reaction including redness up to the back of ears post operatively. The removal of dressing and fexofenadine after first few days of piriton to alleviate itching. However then erythema spread, dressing was removed and fexofenadine given and good relief. 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 Key12477724
MDR Text Key271583990
Report Number2210968-2021-08474
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2021
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: 09/15/2021 Patient Sequence Number: 1
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