Brand Name | ESTEEM + DRAINABLE POUCH EXTENDED WEAR (64MM) |
Manufacturer (Section D) |
CONVATEC DOMINICAN REPUBLIC, INC. |
carretera sanchez, km. 18.2 |
parque industrial itabo, s.a. |
san cristobal, haina 3310 2 |
DR 33102 |
|
Manufacturer Contact |
matthew
walenciak, director
|
211 american ave. |
greensboro, NC 27409
|
9083779293
|
|
MDR Report Key | 4948762 |
MDR Text Key | 6640666 |
Report Number | 9618003-2015-00038 |
Device Sequence Number | 1 |
Product Code |
EZQ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
07/09/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | 416976 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/09/2015 |
Initial Date FDA Received | 07/27/2015 |
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 |
Treatment | LIPITOR |
Patient Outcome(s) |
Required Intervention;
|
Patient Weight | 62 |
|
|