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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC NATURA NOT APPLICABLE

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CONVATEC DOMINICAN REPUBLIC INC NATURA NOT APPLICABLE Back to Search Results
Model Number 402203
Device Problem Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Based on the available information, this event is deemed to be a reportable malfunction. An investigation was performed to determine the root cause associated with the investigation wafer disc decentralization, complaint malfunction (skin barrier starter hole is defective, e. G. Misalignment or off center, leakage may occur), for lots manufactured in (b)(4). The cause and effect investigation was performed.   it was determined that the following probable root causes and opportunities were identified: machinery is the root cause of this incident.   it is concluded that all the machinery/ tooling items complied when compared against drawing specifications, however due to the demands of the process, these tooling require a dimension modification to reduce the variability of the process. Observations include:  misalignment of the wafer loading pins, misalignment of the upper wafer loading plate and fixation of the upper wafer loading plate and lower wafer loading plate. Actual testing method of (random hourly sampling) may not effectively capture the defects prior to packaging, it is suggested the implementation of a continuous testing method to anticipate to all of the peaks. A certification of the operators who have direct influence due to the ¿flange/wafer loading¿ process in operations, to reduce the learning curve effect in process and guarantee the training effectiveness. This should be performed in conjunct with the quality inspector, process engineer of such line and the supervisor. Actions will be taken for each factor and will be summarized on a corrective action / preventive actions (capa) plan. The investigation associated with this event is approved and complete.   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
It was reported that "precut hole off center. " no harm reported. Photos depicting the reported complaint issue were provided by the complainant.
 
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Brand NameNATURA
Type of DeviceNOT APPLICABLE
Manufacturer (Section D)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal
Manufacturer (Section G)
CONVATEC DOMINICAN REPUBLIC INC
km 18.5 parque industrial
itabo, s.a. haina
san cristobal
Manufacturer Contact
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
MDR Report Key7919779
MDR Text Key122460117
Report Number9618003-2018-01823
Device Sequence Number1
Product Code EXB
Combination Product (y/n)N
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number402203
Device Lot Number7L01060
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 Received09/10/2018
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

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