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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC INC L3O0200 - NATURA POUCH, COLOSTOMY Back to Search Results
Model Number 401502
Device Problem Sharp Edges (4013)
Patient Problem Tissue Breakdown (2681)
Event Type  Injury  
Manufacturer Narrative
(b)(6). Based on the available information, this event is deemed to be a serious injury. 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 he was seen by his surgeon last year and had a polyp type "bump" removed from his stoma. The surgeon used sutures to the area. His stoma was prolapsed up to 1. 5" and he felt the bump developed due to the stoma rubbing against the "sharp" flange on the pouch. The bump had returned. He did not report any cuts to the stoma. Issue was not related to leakage. Appliance change procedure was with water only. The end user continued to use the product. No photo is available at this time.
 
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Brand NameL3O0200 - NATURA
Type of DevicePOUCH, COLOSTOMY
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
7900 triad center drive
suite 400
greensboro, NC 
3365424681
MDR Report Key11751264
MDR Text Key248145562
Report Number9618003-2021-00930
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 04/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number401502
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 Received04/07/2021
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

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