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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT Back to Search Results
Model Number CLR222US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Local Reaction (2035); Blister (4537)
Event Date 12/15/2020
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. Was there any medical or surgical intervention performed to threat the reaction (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? yes. If so, please clarify. Patient wan put on additional abx-keflex and bactrim last week. What is the most current patient status? pat was admitted to the hospital in cheyenne on (b)(6) 2020 and released on 12. 20. 20. While in the hospital they gave him steroids and iv bene drill and the patient also suspected mrsa infection. Can you identify the lot number of the product that was used? no. Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no. The following information has been requested however 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. Please describe how 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) has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? what is the current status of the patient?.
 
Event Description
It was reported a patient underwent an acl revision procedure on (b)(6) 2020 and topical skin adhesive with mesh was used. About one week post op, the patient experienced redness and irritated blisters around the application site. Patient was put on additional abx-keflex and bactrim. Patient was admitted to the hospital on (b)(6) 2020 and released on (b)(6) 2020. While in the hospital administered steroids and iv benedryl. Patient also suspected mrsa infection. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
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
00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082182213
MDR Report Key11195848
MDR Text Key227731193
Report Number2210968-2021-00459
Device Sequence Number1
Product Code OMD
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLR222US
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
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: 01/19/2021 Patient Sequence Number: 1
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