Brand Name | ACTIVE LIFE PCH STD TAN 32MM |
Type of Device | POUCH, COLOSTOMY |
Manufacturer (Section D) |
CONVATEC DOM. REPUBLIC INC |
carr. sanchez, km. 18.5 |
parque industrial, haina |
san cristobal, 33102 |
DR 33102 |
|
Manufacturer Contact |
jeanette
johnson
|
7900 triad center drive |
greensboro, NC 27409
|
3365424681
|
|
MDR Report Key | 5289433 |
MDR Text Key | 33276321 |
Report Number | 9618003-2015-40099 |
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 |
Patient
|
Type of Report
| Initial |
Report Date |
11/06/2015 |
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 |
No Information
|
Device Model Number | 022759 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/06/2015 |
Initial Date FDA Received | 12/11/2015 |
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 |
Unknown
|
Patient Sequence Number | 1 |
Treatment | IBUPROFEN METFORMIN, |
Patient Weight | 100 |
|
|