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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE CUTANEOUS TISSUE ADHESIVE WITH MESH

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ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE CUTANEOUS TISSUE ADHESIVE WITH MESH Back to Search Results
Catalog Number CLR422
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Local Reaction (2035); Fluid Discharge (2686)
Event Date 11/14/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional information was requested however not received. If further details are received at a later date a supplemental medwatch will be sent. Date of hip replacement procedure? confirm date of reaction (b)(6) 2020? it was noted that antibiotics were prescribed, please provide details? it was also noted patient was readmitted for wound drainage, was any other medical or surgical interventions performed? please describe how the adhesive was applied. Was the prineo was completely dry prior to applying the dressing? 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) has the patient previously 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? can you identify the product code and lot number of the product that was used? what is the current status of the patient? informed the product will not be returned. 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 total hip replacement on an unknown date in 2020 and topical skin adhesive with mesh was used. The patient had an adverse skin reaction with inflammation, redness and discharge, to adhesive after patient was discharged home. Patient was readmitted for superficial drainage of wound and antibiotics. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
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
00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key11362405
MDR Text Key234325953
Report Number2210968-2021-01680
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K163645
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 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR422
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2021
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: 02/22/2021 Patient Sequence Number: 1
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