• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
Event Date 01/01/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional information: did the patient experience a post-op device malfunction? no, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? --yes, did the patient require revision surgery or hardware removal? no, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? yes, prescription for allergy (antihistaminic injection), patient status/ outcome / consequences? yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc. )? inflammation and red itchy skin, was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe. Severe allergic reaction (redness and inflammation), is the patient part of a clinical study unknown, (b)(6), device property of? none, device in possession of? none. Additional information has been requested and obtained. If further details are received at a later date a supplemental medwatch will be sent. Is a photo available of the patient reaction? yes. What was the procedure date? procedure date is (b)(6) 2022, the surgeon reported to us on (b)(6), and complaint submitted the same day. What date /day post op was the reaction noted? 1 week after the case. Please describe how was the adhesive was applied. What prep was used prior to, during or after adhesive use? was a dressing placed over the incision? if so, what type of cover dressing used? after the subcuticular closure with stratafix monocryl for the skin in a total knee replacement procedure, the prineo was applied on the incision after it was cleaned and dried, and the patient was discharged. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no. Is the patient hypersensitive to pressure sensitive adhesives? no. Were any patch or sensitivity tests performed? no. Patient demographics: initials / id, gender, age or date of birth; bmi. Sa female, (b)(6). Patient pre-existing medical conditions (ie. Allergies, history of reactions) no history of reactions. Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? no. Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no. Current patient status. Recovered. How many prineo products were used during the knee replacement procedure (2 ips entered)? one pc. No product is available for return.
 
Event Description
It was reported a patient underwent a total knee replacement on (b)(6) 2022 and topical skin adhesive was used. 1 week after, when the patient came back to check the wound, the surgeon found that the wound was red and itchy. The surgeon thinks it's because of the adhesive as the skin reaction of the wound takes exactly the shape of the adhesive mesh. It was treated with prescription for allergy (antihistaminic injection). Additional information has been requested.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
Type of DeviceSURGICAL 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
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13474017
MDR Text Key286760106
Report Number2210968-2022-00881
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeKU
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2022
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
Date Manufacturer Received01/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/07/2022 Patient Sequence Number: 1
Treatment
STRATAFIX MONO UNKNOWN
-
-