Brand Name | L3O0100 - ACTIVE LIFE |
Type of Device | POUCH, COLOSTOMY |
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 Key | 14390047 |
MDR Text Key | 291635977 |
Report Number | 9618003-2022-00547 |
Device Sequence Number | 1 |
Product Code |
EZQ
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/20/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/13/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | 022771 |
Device Lot Number | 1J01506 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Manufacturer Received | 09/29/2023 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 09/17/2021 |
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 |
Patient Sex | Male |
|
|