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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH ADHESIVE; SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 22CM MSH ADHESIVE; SURGICAL SEALANT Back to Search Results
Model Number CLR222US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Rash (2033)
Event Date 02/26/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).(b)(4).The hospital hasn't changed the skin prep recently to her knowledge.She has good application technique minus using her glove to smear prineo on.I advised her not to do that and make sure she only applies one thin coat.I also said to make sure you clean any excess glue off.Physician assistant stated using glove to smear adhesive on.Contrary to instructions for use.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.What prep was used prior to, during or after adhesive use? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? patient demographics:, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient used or been 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? what is the physician¿s opinion as to the etiology of or contributing factors to this event? no product available for return.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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 arthroplasty procedure (b)(6) 2022 and topical skin adhesive was used.Post-op to the patient had reaction, rash.On (b)(6) 2022: rash.On (b)(6) 2022: office follow up, otc benadryl, rx clobetasol 0.05%.Removed adhesive, rx cefadroxil.On (b)(6) 2022: 6 week follow up- resolved.Additional information has been requested.
 
Manufacturer Narrative
Product complaint#: (b)(4).Additional information provided.If further details are received at a later date a supplemental medwatch will be sent.Surgeon has provided the following information: he uses chlorhexidine prep, ioban drape, no changes in 15 yrs.Leave adhesive on patient for 4-5weeks post op, don't take off for a while.Closes deep layers, suture barbed subcuticular then physician assistant closes with adhesive.Sales rep addressed proper technique as per the ifu and optimized device performance.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.
 
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Brand Name
DERMABOND PRINEO 22CM MSH ADHESIVE
Type of Device
SURGICAL 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
9083863534
MDR Report Key15474427
MDR Text Key300564260
Report Number2210968-2022-07824
Device Sequence Number1
Product Code OMD
UDI-Device Identifier10705031230996
UDI-Public10705031230996
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician Assistant
Type of Report Initial,Followup
Report Date 10/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCLR222US
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/06/2022
Initial Date FDA Received09/23/2022
Supplement Dates Manufacturer Received09/30/2022
Supplement Dates FDA Received10/19/2022
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? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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