• 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 Wound Dehiscence (1154); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Local Reaction (2035); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)
Event Date 09/01/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Device not returned. Additional information has been requested and obtained. If further details are received at a later date a supplemental medwatch will be sent. Do you have a photo of your reaction? yes. Please provide the confirm the date of surgery was (b)(6) 2021. Date of surgery (b)(6) 2021. Was any surgical intervention provided, please describe? no surgical intervention for reaction. Product removed w/txn with steroid cream clobetasol propionate. 05% around wound. Were you treated with prescription medications (not over the counter) please describe? claritin redi tabs purchased otc 1 qd prescribed of no benefit and stopped after 3 days. Steroid ointment rx clobetasol propionate. 05% applied around wound after dermabond prineo was removed additional information was requested however not received. If further details are received at a later date a supplemental medwatch will be sent. What medical and/or surgical intervention was performed to address the wound dehiscence and /or reaction? please describe how was the adhesive was applied? please describe how was 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: id, age or date of birth; bmi. Has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? do you have the product code and/or lot number used? current patient status. No product is available for return. 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 (b)(6) 2021 and topical skin adhesive was used. Twenty-four hours after patient developed irritation, redness and itching on the wound where the product was applied. There is also a yellow substance draining out of the wound. The area above the wound all the way up to the patients breast is splotchy. The patient is taking claritin to help with the symptoms. Product removed with steroid cream clobetasol propionate. 05% around wound. Also, there is some bleeding coming from partially open spots on the wound. 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
road 183, km. 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12656695
MDR Text Key277171377
Report Number2210968-2021-09895
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
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: 10/19/2021 Patient Sequence Number: 1
-
-