• 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 Wound Dehiscence (1154); Cellulitis (1768); Fever (1858); Inflammation (1932); Necrosis (1971); Swelling (2091); No Code Available (3191)
Event Date 09/06/2016
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.
 
Event Description
It was reported that the patient underwent a total knee arthroplasty procedure on (b)(6) 2016 and the topical skin adhesive was used after multi-layered closure followed by an abd dressing and ace wrap. Post-operatively, the patient noticed blistering and it was evaluated by a doctor on the skin both medial and lateral under the topical skin adhesive on (b)(6) 2016. Blisters were aspirated for serosanguinous drainage and cultures were negative. The topical skin adhesive was left in a place and sloughed off spontaneously. The patient was evaluated with some improvement on (b)(6) 2016. Last week, the patient was admitted to the hospital with possible cellulitis and further evaluation and treatment of were indicated. The patient had come down with a 103 degree fever, and his knee swelled up. The wound edges had become necrotic and have shown complete dehiscence. The patient will now need a debridement, wound vac, and skin grafting. Now the patient is being refered to a specialist to continue a treatment.
 
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 Key6077246
MDR Text Key59114694
Report Number2210968-2016-14709
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 09/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2016
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 Received10/13/2016
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: 11/03/2016 Patient Sequence Number: 1
Treatment
ACE WRAP, ABD DRESSING
-
-