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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3W0800 - GRANUFLEX NOT APPLICABLE

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CONVATEC DOMINICAN REPUBLIC INC L3W0800 - GRANUFLEX NOT APPLICABLE Back to Search Results
Model Number 187951
Device Problem Difficult to Remove (1528)
Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545)
Event Type  malfunction  
Event Description
It was reported by an end user to company representative that the dressing was hard to remove, resulted in pain and skin redness under the mass. The end user stopped using the product. No photo is available at this time.
 
Manufacturer Narrative
Complainant country: (b)(6). Based on the available information, this event is deemed to be a reportable malfunction. 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).
 
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Brand NameL3W0800 - GRANUFLEX
Type of DeviceNOT APPLICABLE
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
7815 national service road
suite 600
greensboro, NC 
3365424679
MDR Report Key13275641
MDR Text Key286583546
Report Number9618003-2022-00005
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number187951
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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