• 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. PRINEO SKIN CLOSURE SYSTEM 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. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT Back to Search Results
Catalog Number CLR222US
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Erythema (1840); Swelling (2091); Reaction (2414); No Code Available (3191)
Event Date 09/22/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. Additional information was requested and the following was obtained: what was the location and incision size of prineo application; back about 19cm; what prep was used prior to prineo application: yes; please describe how the adhesive was applied on the tape: per directions; was a dressing placed over the incision, if so, what type of cover dressing used: no as the prineo was removed immediately; do you have any photos: no!; does the patient have any other exposure to adhesives (nail glue): unknown; when the product was removed, what was another method used to close the incision:yes; is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde: unknown; can you identify the lot number of the product that was used: no; what is the current condition of the patient: unknown.
 
Event Description
It was reported that the patient underwent a laminectomy procedure for l4-5 on (b)(6) 2016 and the topical skin adhesive was used. During the procedure, after applying a topical skin adhesive, the patient's skin immediately began to turn red and puffy underneath it; therefore, the doctor decided to remove it. It was also reported that steroids, strips, mastisol, dry 4x3's and tape were used to complete the procedure. The current condition of the patient is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRINEO SKIN CLOSURE SYSTEM
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
982 road 183 km 8.3
san lorenzo PR 00754
Manufacturer Contact
kenneth clark
route 22 westp o box 151
somerville, NJ 08876
9082183547
MDR Report Key6020250
MDR Text Key57073004
Report Number2210968-2016-14324
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 09/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2016
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/12/2016 Patient Sequence Number: 1
-
-