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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0675 - ESTEEM+

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CONVATEC DOMINICAN REPUBLIC INC L3O0675 - ESTEEM+ Back to Search Results
Model Number 421022
Device Problem Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that, the wafer with starter hole was off centered. The product was not used. No photo is available at this time.
 
Manufacturer Narrative
Device 2 of 2. Common device name: pouch, colostomy. Product code: ezq. Complainant state: (b)(6). Event country: (b)(6). Correction - contact office address: (b)(4). Pma /510(k) #: exempt. Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. Fda registration number (b)(4).
 
Manufacturer Narrative
Device 2 of 2. Common device name: pouch, colostomy. Product code: ezq. Complainant state: (b)(6). Event country: (b)(6). Correction - contact office address: (b)(4). Pma /510(k) #: exempt. Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. Fda registration number (b)(4).
 
Event Description
It was reported that, the wafer with starter hole was off centered. The product was not used. No photo is available at this time.
 
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Brand NameL3O0675 - ESTEEM+
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal 91000
DR 91000
Manufacturer (Section G)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal 91000
DR 91000
Manufacturer Contact
pamela meadows
7815 national service road
suite 600
greensboro, NC 
3365424679
MDR Report Key13106620
MDR Text Key286136283
Report Number9618003-2021-02927
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number421022
Device Lot Number1B03448
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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