• 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 42CM CUTANEOUS TISSUE ADHESIVE WITH MESH

  • 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 42CM CUTANEOUS TISSUE ADHESIVE WITH MESH Back to Search Results
Catalog Number CLR422
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Skin Irritation (2076); No Code Available (3191)
Event Date 05/02/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified. Additional information has been requested, and the following was obtained: what prep was used prior to, during or after prineo use? cetrimide pre-op wash. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no. Is the patient hypersensitive to pressure sensitive adhesives? query mention of sensitivity in the past to tapes with a previous surgeon. Were any patch or sensitivity tests performed? no. Do you have the product lot number involved? see impacted product. What is the physicians opinion of the contributing factors to the reaction? n/k. What is the most current patient status? tba. Is the product or representative sample (product from the same lot number) available for evaluation? no. Patient demographics: initials / id; age or date of birth; bmi ; gender: provided in initial report. Patient pre-existing medical conditions (ie. Allergies, history of reactions) query mention of sensitivity in the past to tapes with a previous surgeon. Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no, not with dr ¿ she has had surgery with other surgeons so unable to say 100%. To date device not received. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported a patient underwent a revision abdominoplasty to repair hernia on an (b)(6) 2019 and topical skin adhesive was used. 3 days post operatively, the patient had a reaction to the adhesive dressing. The patient had redness, bumps and secretion for the wound. The patient's dressing was removed and the patient was placed on corticosteroid treatment, prescribed bactrim and prednisolone. The area was re-dressed with mefix tape additional information was requested.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDERMABOND PRINEO 42CM
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8670827
MDR Text Key147064225
Report Number2210968-2019-82415
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeAS
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 05/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2019
Device Catalogue NumberCLR422
Device Lot NumberMGH123
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/09/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/07/2018
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: 06/05/2019 Patient Sequence Number: 1
-
-