Brand Name | DUODERM EXTRA THIN CGF (CONTROL GEL FORMULA) |
Type of Device | DRESSING, WOUND, OCCLUSIVE |
Manufacturer (Section D) |
CONVATEC INC |
211 american ave. |
greensboro NC 27409 |
|
Manufacturer Contact |
matthew
walenciak
|
211 american ave. |
greensboro, NC 27409
|
9083779293
|
|
MDR Report Key | 4840401 |
MDR Text Key | 5945221 |
Report Number | 1049092-2015-00332 |
Device Sequence Number | 1 |
Product Code |
NAD
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K891696 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative,company represent |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/19/2015 |
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 |
Health Professional
|
Device Model Number | 187955 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/19/2015 |
Initial Date FDA Received | 06/11/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 07/01/2015
|
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 |
Initial
|
Patient Sequence Number | 1 |
|
|