Brand Name | UNIVERSAL WIRE CUTTERS 150MM |
Type of Device | UTILITY FORCEPS |
Manufacturer (Section D) |
AESCULAP AG & CO KG |
tuttlingen DE 75832 |
|
Manufacturer (Section G) |
AESCULAP AG & CO KG |
po box 40 |
|
tuttlingen 7850 1 |
GM
78501
|
|
Manufacturer Contact |
michelle
link
|
615 lambert pointe dr |
hazelwood, MO 63042
|
3145515938
|
|
MDR Report Key | 4351259 |
MDR Text Key | 5173712 |
Report Number | 2916714-2014-00932 |
Device Sequence Number | 1 |
Product Code |
HXZ
|
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,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/05/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | DP501R |
Device Catalogue Number | DP501R |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/14/2014
|
Initial Date FDA Received | 12/12/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|