Brand Name | PREMIER FLEXTEND DRAINABLE POUCH WITH TAPE BORDER |
Type of Device | PREMIER FLEXTEND DRAINABLE POUCH WITH TAPE BORDER |
Manufacturer (Section D) |
HOLLISTER INCORPORATED |
2000 hollister drive |
libertyville IL 60048 3781 |
|
Manufacturer (Section G) |
HOLLISTER INCORPORATED |
366 draft avenue |
|
stuarts draft VA 24477 9998 |
|
Manufacturer Contact |
linda
wisowaty
|
2000 hollister drive |
libertyville, IL 60046-3781
|
8476802170
|
|
MDR Report Key | 11231471 |
MDR Text Key | 228855191 |
Report Number | 1119193-2021-00003 |
Device Sequence Number | 1 |
Product Code |
EXB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | N/A |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/26/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/26/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | 8331 |
Device Lot Number | UNKNOWN |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/19/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Weight | 68 |