Brand Name | NPWT PRO NPWT THERAPY DEVICE |
Type of Device | NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP |
Manufacturer (Section D) |
CIRPRO DE DELICIAS S.A. DE C.V. |
las virgenes industrial park, |
delicias, chihuahua 33019 |
MX 33019 |
|
Manufacturer (Section G) |
CIRPRO DE DELICIAS S.A. DE C.V. |
las virgenes industrial park, |
|
delicias, chihuahua 33019 |
MX
33019
|
|
Manufacturer Contact |
patricia
tucker
|
3651 birchwood drive |
waukegan, IL 60085
|
|
MDR Report Key | 14107033 |
MDR Text Key | 298713812 |
Report Number | 1423537-2022-00745 |
Device Sequence Number | 1 |
Product Code |
OMP
|
UDI-Device Identifier | 10885380103520 |
UDI-Public | 10885380103520 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
05/16/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/13/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 6708888 |
Device Catalogue Number | 6708888 |
Device Lot Number | D012100138 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/17/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|