Brand Name | BIOGEL MICRO SURGICAL GLOVES |
Manufacturer (Section D) |
MOLNLYCKE HEALTH CARE |
norcross GA |
|
Manufacturer Contact |
curtis
truesdale
|
5550 peachtree parkway |
suite 500 |
norcross, GA 30092
|
6782507928
|
|
MDR Report Key | 3865421 |
MDR Text Key | 19405363 |
Report Number | 3004763499-2014-00005 |
Device Sequence Number | 1 |
Product Code |
KGO
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K970924 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/08/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/10/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 30570 |
Device Lot Number | 13G161 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 01/08/2014 |
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 |
Unknown
|
Patient Sequence Number | 1 |
|
|