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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3O0100 - ACTIVE LIFE; POUCH, COLOSTOMY

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CONVATEC DOMINICAN REPUBLIC INC L3O0100 - ACTIVE LIFE; POUCH, COLOSTOMY Back to Search Results
Model Number 175777
Device Problems Fluid/Blood Leak (1250); Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Device 2 of 5.(b)(4).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.(b)(4).
 
Event Description
The end user stated that the starter hole was off centered on all five of the wafers noted upon removal from the box.He did use the products but could not recall how many he used.His normal wear time was 3 to 4 days, but these lasted about 2 days before they developed a leak.No harm was reported and no photo is available at this time.
 
Event Description
To date no additional patient or event details have been received.
 
Manufacturer Narrative
G1: correction (g1) - contact office address: (b)(6) no sample, video or photo was received for evaluation; for that reason, the malfunction reported by the customer could not be confirmed.Batch record review results: lot 0h01741 was manufactured on 08/19/2020 in the cvx1pc manufacturing line, with a total of(b)(4) mkus.On 19/aug/2021, compliance engineer id (b)(6) performed a batch record review, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom, under sap material 1000616 and manufacturing order 1535601.No issues related to the defect were found in the documentation.On(b)(6)2021 a complaint search for lot 0h01741 and malfunction code ost-pmc1.8 / ost-pmc01.08 skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only) was carried out and as a result, no additional complaints were found; therefore, no potential trend is observed.As per complaint manufacturing investigation procedure wi-0359, version 5.0, it is not required to open a nonconformance report (ncr) for type 2 complaints which were not confirmed (this was concluded that this is not a quality issue) and no potential trend is identified.No additional action is required, and this complaint will be closed.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092 manufacturing site: 9618003.
 
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Brand Name
L3O0100 - ACTIVE LIFE
Type of Device
POUCH, COLOSTOMY
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal 91000
DR  91000
MDR Report Key11714973
MDR Text Key247261340
Report Number9618003-2021-00816
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
Type of Report Initial,Followup
Report Date 04/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number175777
Device Lot Number0H01741
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 04/08/2021
Initial Date FDA Received04/23/2021
Supplement Dates Manufacturer Received08/19/2021
Supplement Dates FDA Received08/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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