Brand Name | CARBON STEEL SCALPEL BLADES #22 |
Type of Device | SCALPEL BLADES |
Manufacturer (Section D) |
AESCULAP AG |
po box 40 |
tuttlingen, 78501 |
GM 78501 |
|
Manufacturer (Section G) |
AESCULAP AG |
po box 40 |
|
tuttlingen, 78501 |
GM
78501
|
|
Manufacturer Contact |
nicole
broyles
|
615 lambert pointe dr |
hazelwood, MO 63042
|
|
MDR Report Key | 8382149 |
MDR Text Key | 137539053 |
Report Number | 9610612-2019-00149 |
Device Sequence Number | 1 |
Product Code |
GES
|
Combination Product (y/n) | N |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/01/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/01/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/31/2023 |
Device Model Number | BB522 |
Device Catalogue Number | BB522 |
Device Lot Number | 4509589491 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/22/2019 |
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 02/26/2019 |
Device Age | 4 YR |
Date Manufacturer Received | 02/06/2019 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/22/2018 |
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 |