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

MAUDE Adverse Event Report: CONVATEC INC. NATURA 2 PC STOMAHESIVE WAFER W/FLEX COLLAR ; PROTECTOR, OSTOMY

  • 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
 

CONVATEC INC. NATURA 2 PC STOMAHESIVE WAFER W/FLEX COLLAR ; PROTECTOR, OSTOMY Back to Search Results
Model Number 125265
Device Problem Leak/Splash (1354)
Patient Problems Wound Dehiscence (1154); Tissue Breakdown (2681)
Event Date 12/10/2012
Event Type  Injury  
Event Description
End-user reported that the right, middle and left area of abdominal skin presented as an open wound with leakage and peeling skin, located under all of wafer; tape collar extending beyond the appliance.
 
Manufacturer Narrative
Based on the available info, this event is deemed a serious injury.It is reported that the following skin care is performed by end-user: uses alcohol; dove soap; and stomahesive powder.End-user was provided instructions in appropriate and proper skin care.It is reported that end -user will try sur-fit natura moldable convex product with eakin cohesive seals.End-user was encouraged to follow-up with a health care provider if condition persists.Lastly, it is reported that end-user has scheduled a visit to see dermatologist.No additional pt/event details have been provided to date.A return sample for evaluation is not expected.Should additional information become available, a follow report will be submitted.
 
Manufacturer Narrative
Additional information was received on september 23, 2015.The product associated with lot#3d00375 was manufactured according to specification.After a thorough batch review no discrepancies or non-conformances were discovered.There is not enough information to conclude the product did not meet specification and perform as intended.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Previous investigation is applicable to this complaint.Therefore, this complaint will remain open until completion of the investigation.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
 
Manufacturer Narrative
The product associated with batch 3d00375 was made according to specification.After detailed batch review, no discrepancies, including non-conformances/deviations, were found.Product monitoring reviews will monitor for product trends if this issue were to reoccur.Previous non-conformance is applicable to this complaint and is closed.No further actions are required, and this complaint will be closed.The complaint/incidence data-post market analysis (trend analysis), clinical review, root cause analysis and risk assessment indicate a consistent rate of complaints by the end user is a result of skin complications caused by a variety of external factors not related to the design, materials, and/or processes of the product.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NATURA 2 PC STOMAHESIVE WAFER W/FLEX COLLAR
Type of Device
PROTECTOR, OSTOMY
Manufacturer (Section D)
CONVATEC INC.
211 american ave.
greensboro NC 27409
Manufacturer Contact
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3362973009
MDR Report Key3580483
MDR Text Key4060633
Report Number1049092-2014-00026
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K830945
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative,company representative
Reporter Occupation Not Applicable
Type of Report Initial,Followup
Report Date 12/10/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/11/2018
Device Model Number125265
Device Catalogue Number125265
Device Lot Number3D00375
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/10/2013
Initial Date FDA Received01/08/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/21/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight100
-
-