Brand Name | GRIESHABER ADVANCED DSP TIP SCISSORS |
Type of Device | SCISSORS, OPHTHALMIC |
Manufacturer (Section D) |
ALCON GRIESHABER AG |
winkelriedstrasse 52 |
schaffhausen 8203 |
SZ 8203 |
|
Manufacturer (Section G) |
ALCON GRIESHABER AG |
winkelriedstrasse 52 |
|
schaffhausen 8203 |
SZ
8203
|
|
Manufacturer Contact |
jonathan
schlech
|
6201 south freeway |
mail stop ab2-6 |
fort worth, TX 76134
|
8007579780
|
|
MDR Report Key | 18424141 |
MDR Text Key | 331907115 |
Report Number | 3003398873-2024-00002 |
Device Sequence Number | 1 |
Product Code |
HNF
|
UDI-Device Identifier | 07612717071070 |
UDI-Public | 07612717071070 |
Combination Product (y/n) | N |
Reporter Country Code | SF |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
01/02/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/02/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 725.52P |
Device Lot Number | 15C47C |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 12/08/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/08/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 49 YR |
Patient Sex | Female |