Brand Name | PE ADULT-PED DRY/ WET 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 |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9194332672
|
|
MDR Report Key | 16622377 |
MDR Text Key | 312218332 |
Report Number | 3004365956-2023-00023 |
Device Sequence Number | 1 |
Product Code |
KDQ
|
UDI-Device Identifier | 34026704631231 |
UDI-Public | 34026704631231 |
Combination Product (y/n) | N |
Reporter Country Code | SP |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial,Followup |
Report Date |
03/16/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/27/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | IPN028442 |
Device Catalogue Number | A-6000-08LF |
Device Lot Number | 74K2200575 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 05/01/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/12/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | NONE REPORTED; NONE REPORTED; NONE REPORTED |