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

MAUDE Adverse Event Report: POLYGANICS INNOVATIONS BV VIVOSORB VIVOSORB SHEET

  • 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
 

POLYGANICS INNOVATIONS BV VIVOSORB VIVOSORB SHEET Back to Search Results
Model Number FS01-035/20
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2020
Event Type  Injury  
Manufacturer Narrative
The device is not available for investigation. The device was released according to specification. As the surgeon indicated, the patient group might be of influence in the results: prior to the study, the device was already used in dupuytren patients successfully. However, the cases within the study seem to be more severe with regards to disease symptoms, surgical intervention and/or postoperative training regimen, which might be (one of) the reasons causing the adverse events. In addition, the device was placed very near to the surface of the wound bed, which might lead to higher risk for protrusion due to the limited soft tissue covering the device. The surgeon is currently investigating the cases and results to be able to identify the cause of the adverse events.
 
Event Description
A post-market investigator-driven trial is currently performed (an academic prospective interventional cohort study with patients suffering dupuytren disease) with minimal invasive surgery and vivosorb in order to improve deformity of the finger. This is within the scope of the vivosorb intended use. At the 2-week follow-up visit, two patients experienced protrusion of (part of) vivosorb. Limited information from one patient only has been obtained, see below: surgery begin (b)(6) 2020. Vivosorb was cut into pieces; placed on multiple locations and fixated with sutures in the palm of the hand, very close under the skin and near the wound bed. At the 2-weeks follow-up after surgery (b)(6) protrusion occurred from a part of the vivosorb; patient picked at the wound and pulled loose pieces of product. The surgeon cleaned the wound bed, removed remnants of vivosorb, and closed the wound. The other pieces of vivosorb are still in place.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVIVOSORB
Type of DeviceVIVOSORB SHEET
Manufacturer (Section D)
POLYGANICS INNOVATIONS BV
rozenburglaan 15a
groningen, groningen 9727D L
NL 9727DL
Manufacturer (Section G)
POLYGANICS INNOVATIONS BV
rozenburglaan 15a
groningen, 9727D L
NL 9727DL
Manufacturer Contact
betty ijmker
rozenburglaan 15a
groningen, 9727D-L
NL   9727DL
MDR Report Key10064803
MDR Text Key195097730
Report Number3004504732-2020-00001
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K042811
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial
Report Date 03/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/03/2020
Device Model NumberFS01-035/20
Device Catalogue NumberFS01-035/20
Device Lot NumberFSA2018040412
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2018
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: 05/18/2020 Patient Sequence Number: 1
-
-