Brand Name | SIMPLEX HV WITH GENTAMICIN US 1 PACK |
Type of Device | SIMPLEX HV GENTAMICIN |
Manufacturer (Section D) |
AAP BIOMATERIALS GMBH |
lagerstr.11-15 |
dieburg, 64807 |
GM 64807 |
|
Manufacturer (Section G) |
AAP BIOMATERIALS GMBH |
lagerstr.11-15 |
|
dieburg 64807 |
GM
64807
|
|
Manufacturer Contact |
lydia
heimann
|
lagerstr. 11-15 |
dieburg, 64807
|
GM
64807
|
071929107
|
|
MDR Report Key | 5522213 |
MDR Text Key | 41015727 |
Report Number | 9615014-2016-00003 |
Device Sequence Number | 1 |
Product Code |
MBB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | 510(K)123081 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,health profession |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/14/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/24/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/31/2017 |
Device Catalogue Number | 6195-1-001 |
Device Lot Number | 530BA903GW |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/11/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/04/2014 |
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 |