Brand Name | ZIMMER AIR DERMATOME |
Type of Device | DERMATOME |
Manufacturer (Section D) |
ZIMMER SURGICAL, INC. |
200 west ohio avenue |
dover OH 44622 |
|
Manufacturer (Section G) |
ZIMMER SURGICAL, INC. |
200 west ohio avenue |
|
dover OH 44622 |
|
Manufacturer Contact |
christina
arnt
|
56 e. bell drive |
warsaw, IN 46582
|
5745273773
|
|
MDR Report Key | 11776270 |
MDR Text Key | 249295852 |
Report Number | 0001526350-2021-00524 |
Device Sequence Number | 1 |
Product Code |
GFD
|
UDI-Device Identifier | 00889024375901 |
UDI-Public | (01)00889024375901(11)190121(10)64277076 |
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 |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
05/05/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/05/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 00880100100 |
Device Lot Number | 64277076 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/12/2021 |
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 04/30/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/21/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | N/A |
Patient Sequence Number | 1 |