Brand Name | AAMI 4 BREATHABLE RAG BNS XL |
Type of Device | GOWN, SURGICAL |
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 dr |
waukegan, IL 60085
|
8478874151
|
|
MDR Report Key | 9461577 |
MDR Text Key | 206827870 |
Report Number | 1423537-2019-00379 |
Device Sequence Number | 1 |
Product Code |
FYA
|
UDI-Device Identifier | 10885380134425 |
UDI-Public | 10885380134425 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/12/2019 |
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 |
Health Professional
|
Device Model Number | 39045NA |
Device Catalogue Number | 39045NA |
Device Lot Number | 0679DD2 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/12/2019 |
Initial Date FDA Received | 12/12/2019 |
Was Device Evaluated by Manufacturer? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 31 YR |
Patient Weight | 60 |
|
|