Brand Name | CARBON STEEL SCALPEL BLADES #10 |
Type of Device | GENERAL SURGICAL INSTRUMENTS |
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 drive |
hazelwood, MO 63042
|
3145515988
|
|
MDR Report Key | 8476219 |
MDR Text Key | 140740800 |
Report Number | 9610612-2019-00219 |
Device Sequence Number | 1 |
Product Code |
GES
|
Combination Product (y/n) | N |
Reporter Country Code | NO |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/02/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/02/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 12/31/2022 |
Device Model Number | BB510 |
Device Catalogue Number | BB510 |
Device Lot Number | 4509299706 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 03/26/2019 |
Date Manufacturer Received | 03/06/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/21/2018 |
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 |