Type of Device | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP |
Manufacturer (Section D) |
KCI USA, INC. |
12930 ih 10 west |
san antonio TX 78249 |
|
MDR Report Key | 10733073 |
MDR Text Key | 213004299 |
Report Number | 10733073 |
Device Sequence Number | 1 |
Product Code |
OMP
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
10/15/2020 |
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
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 10/15/2020 |
Event Location |
Hospital
|
Date Report to Manufacturer | 10/26/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 10/26/2020 |
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|