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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
Model Number CLR422US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blister (4537)
Event Date 09/30/2021
Event Type  Injury  
Event Description
It was reported patient underwent total knee replacement on (b)(6) 2021 and topical skin adhesive was used. Two days post op, the patient presented with large blisters around the application site. The physician drained the blisters in office. Additional information has been requested.
 
Manufacturer Narrative
Product complaint # (b)(4). (b)(4). Device not returned. Additional information was requested and received. If further details are received at a later date a supplemental medwatch will be sent. Are photos available? photos were sent when complaint called in it was noted the patient had blistering and they were drained in the physician¿s office. Please describe any other medical or surgical intervention required to treat the reaction including start date and results. None what surgical preparation was used prior to, during, or after product use? chloraprep, with ioban drape. How was the product applied? per ifu. Has the patient demonstrated previous hypersensitivity or allergies to cyanoacrylate or formaldehyde? unknown. Has the patient had prior exposure to dermabond, prineo or other skin adhesives? unknown. Does the patient have allergies to medication, food, etc. ? unknown. Was an allergy test performed? if so, please provide results. Unknown. Has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown. Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure. Not available. What is the physician¿s opinion as to the etiology of or contributing factors to this event? concerned but no other opinion expressed. What is the patient's current status? unknown. Surgeon¿s name? (b)(6). Product lot number? unavailable. Was a dressing placed over the incision? if so, what type of cover dressing was used? no dressing placed over the dermabond prineo. No device is available. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
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Brand NameDERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
MDR Report Key12704580
MDR Text Key283754502
Report Number2210968-2021-10400
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
PMA/PMN Number
K163645
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 10/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLR422US
Device Catalogue NumberCLR422US
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2021
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 10/27/2021 Patient Sequence Number: 1
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