Brand Name | AQUACEL AG FOAM HYDROFIBER DRESSING |
Type of Device | DRESSING, WOUND, DRUG |
Manufacturer (Section D) |
CONVATEC, INC. |
211 american avenue |
greensboro NC 27409 |
|
Manufacturer (Section G) |
CONVATEC, INC. |
211 american avenue |
|
greensboro NC 27409 |
|
Manufacturer Contact |
matthew
walenciak
|
211 american ave |
greensboro, NC 27409
|
9083779293
|
|
MDR Report Key | 5150623 |
MDR Text Key | 28301896 |
Report Number | 1049092-2015-00600 |
Device Sequence Number | 1 |
Product Code |
FRO
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K123481 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
09/17/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/14/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/05/2017 |
Device Model Number | 420805 |
Device Lot Number | 2381347 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 09/17/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/06/2015 |
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 |
|
|