Brand Name | PE SAHARA DRY SUCT/DRY SEAL LF 6/CS |
Type of Device | BOTTLE, COLLECTION, VACUUM |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
morrisville NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
parque industrial finsa |
|
nuevo laredo 88275 |
MX
88275
|
|
Manufacturer Contact |
effie
jefferson
|
3015 carrington mill blvd |
morrisville 27560
|
9194332672
|
|
MDR Report Key | 11408264 |
MDR Text Key | 234629285 |
Report Number | 3004365956-2021-00086 |
Device Sequence Number | 1 |
Product Code |
KDQ
|
UDI-Device Identifier | 34026704631668 |
UDI-Public | 34026704631668 |
Combination Product (y/n) | N |
Reporter Country Code | NL |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
02/24/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/03/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | IPN028484 |
Device Catalogue Number | S-1100-08LF |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 02/24/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |