Brand Name | UNKNOWN PERITONEAL CATHETER |
Type of Device | CATHETER, PERITONEAL |
Manufacturer (Section D) |
COVIDIEN MFG SOLUTIONS S.A. |
edificio b20, calle #2 |
alajuela 20101 |
|
Manufacturer (Section G) |
COVIDIEN MFG SOLUTIONS S.A. |
edificio b20, calle #2 |
|
alajuela 20101 |
|
Manufacturer Contact |
jacqueline
st. pierre
|
15 hampshire st. |
mansfield, MA 02048
|
5084524938
|
|
MDR Report Key | 7053576 |
MDR Text Key | 92781709 |
Report Number | 3009211636-2017-05360 |
Device Sequence Number | 1 |
Product Code |
GBW
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/22/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/22/2017 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | UNK PD |
Device Catalogue Number | UNK PD |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 10/31/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
|
|