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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 Problems Skin Irritation (2076); Tissue Damage (2104); Not Applicable (3189)
Event Date 09/01/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). The following information has been requested and obtained. To date the device has not been received. If the further details are received at a later date a supplemental medwatch will be sent. Please clarify the reason for the post-operative admission to the hospital. Procedure was bilateral tka. Post op admission standard practice. Please describe how was the adhesive was applied. Rep not present for case. Application described as per usual, as per ifu. What prep was used prior to, during or after use? 3m chlorohexidine on both knees as per surgeons usual practice. Was a dressing placed over the incision? if so, what type of cover dressing used? on staples knee with chlorohexidine advanced - bactigras. On perineo knee, no additional dressing was said to have been used. Unsure if both knees were censored in recovery. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? surgeon said patient said no allergies. Is the patient hypersensitive to pressure sensitive adhesives? unknown. Were any patch or sensitivity tests performed? no. Patient demographics: initials / id, gender, age or date of birth; bmi unable to access this information. Patient pre-existing medical conditions (ie. Allergies, history of reactions) unable to access this information. Does the patient use or exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails). Unknown. Current patient status. Stable. 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 bilateral total knee (tka) surgery on (b)(6) 2020 and topical skin adhesive with mesh was used. On one knee, patient experienced skin reaction, redness, blistering and removal of adhesive was required. Tegaderm was used, no further issue. Patient post-operative admission to the hospital. 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
9082183429
MDR Report Key10646152
MDR Text Key210401880
Report Number2210968-2020-07765
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeCA
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 09/14/2020
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
Device Model NumberCLR422US
Device Catalogue NumberCLR422US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2020
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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