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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC ACTIVE LIFE POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC INC ACTIVE LIFE POUCH, COLOSTOMY Back to Search Results
Model Number 022771
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Skin Discoloration (2074); Tissue Breakdown (2681); Skin Infection (4544)
Event Type  Injury  
Manufacturer Narrative
Initial emdr is being re-submitted per request of fda on 02-apr-2021. This supplemental is being submitted as an initial mdr due to network issues upon submission on june 06, 2017 which failed to process. Reported to the fda on: 24-oct-2017. Based on the available information, this event is deemed to be a serious injury. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
 
Event Description
End user reported red skin under tape collar to the right side of the wafer which started approximately a couple months ago. Prior to this end user developed an unrelated staphylococcus infection to legs which moved to abdomen and underneath tape collar. She was prescribed bactrim for the staphylococcus infection and was taking prescription cephalexin capsule for the red skin under the tape collar. She reported there was some lessening to the redness under the tape collar. The doctor was uncertain if the issue is related to the staphylococcus infection or to the adhesive on the tape collar. Additionally, it was reported that the end user stated that the red skin started on the right side of the wafer at the same time as the staphylococcus infection on the legs. No pictures were provided and no further details have been provided.
 
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Brand NameACTIVE LIFE
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 Contact
pamela meadows
7815 national service road
suite 600
greensboro, NC 27409
3365424679
MDR Report Key6972600
MDR Text Key243521404
Report Number9618003-2017-00040
Device Sequence Number1
Product Code EZQ
Combination Product (y/n)N
Reporter Country CodeUS
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 02/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number022771
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/24/2017 Patient Sequence Number: 1
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