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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC EST+ DRNPRECUTINVISICLR38MM(1X10) NAI NOT APPLICABLE

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CONVATEC DOMINICAN REPUBLIC INC EST+ DRNPRECUTINVISICLR38MM(1X10) NAI NOT APPLICABLE Back to Search Results
Model Number 421024
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. 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 the starter hole was off center in three wafers. The product was not used and no photo was provided.
 
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Brand NameEST+ DRNPRECUTINVISICLR38MM(1X10) NAI
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 Key8115744
MDR Text Key128894154
Report Number9618003-2018-03652
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 distributor,foreign
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Model Number421024
Device Lot Number8C03437
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 Received11/12/2018
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

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