Brand Name | DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING |
Type of Device | NOT 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 |
pamela
meadows
|
7815 national service road |
suite 600 |
greensboro, NC 27409
|
3365424679
|
|
MDR Report Key | 8160036 |
MDR Text Key | 130335516 |
Report Number | 9618003-2018-04056 |
Device Sequence Number | 1 |
Product Code |
NAD
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/13/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Expiration Date | 01/31/2023 |
Device Model Number | 412002 |
Device Lot Number | 8A06770 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Manufacturer Received | 11/20/2023 |
Was Device Evaluated by Manufacturer? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
A
|
Patient Sequence Number | 1 |
|
|