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

MAUDE Adverse Event Report: UNOMEDICAL S.R.O. L3O0675 - ESTEEM+ POUCH, COLOSTOMY

  • 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
 

UNOMEDICAL S.R.O. L3O0675 - ESTEEM+ POUCH, COLOSTOMY Back to Search Results
Model Number 421821
Device Problem Sharp Edges (4013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Device 1 of 4. Contact office address: (b)(4). Based on the available information, this event is deemed to be a reportable malfunction. This complaint has been evaluated. No lot number is available. A detailed investigation or batch review cannot be conducted. Therefore, this evaluation will be closed. This issue will be monitored through the post market product monitoring review process. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
 
Event Description
The end user reported that her aide pre-cut 4 pouches out of a box of 30. They did not cut with clear edges like her previous pouches. The edges were jagged and she did not feel safe using them. The product was not used. No photo is available at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameL3O0675 - ESTEEM+
Type of DevicePOUCH, COLOSTOMY
Manufacturer (Section D)
UNOMEDICAL S.R.O.
priemyselny park 3,
michalovce 07101
LO 07101
Manufacturer (Section G)
UNOMEDICAL S.R.O.
priemyselny park 3,
michalovce 07101
LO 07101
Manufacturer Contact
pamela meadows
7900 triad center drive
suite 400
greensboro, NC 
3365424681
MDR Report Key11451996
MDR Text Key249710619
Report Number3005778470-2021-00109
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 02/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number421821
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/11/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-