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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 Problem Reaction (2414)
Event Date 03/23/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). The following information has been requested but not received. To date the device has not been received. If the further details are received at a later date a supplemental medwatch will be sent. Procedure name? date of procedure? date of reaction? what was the patient¿s medical history/comorbidities? were there any other post-operative surgical complications than the alleged reaction? 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? patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie. Allergies, history of reactions). Does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails). Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.
 
Event Description
It was reported a patient underwent an unknown procedure on an unknown date in 2020 and topical skin adhesive with mesh was used. The patient had a systemic reaction which resulted in an additional five nights in hospital. Patient given a steroid cream and antihistamines as a treatment. 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.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10646260
MDR Text Key210406082
Report Number2210968-2020-07766
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeAS
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 09/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
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 Received10/22/2020
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: 10/07/2020 Patient Sequence Number: 1
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