Brand Name | HANDPIECE, ELECTRIC 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 |
jennifer
rapsavage
|
56 e. bell drive |
warsaw, IN 46582
|
5745260384
|
|
MDR Report Key | 15825999 |
MDR Text Key | 303939202 |
Report Number | 0001526350-2022-01132 |
Device Sequence Number | 1 |
Product Code |
GFD
|
Combination Product (y/n) | N |
Reporter Country Code | AS |
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,Followup |
Report Date |
02/24/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/18/2022 |
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 | 00882100100 |
Device Lot Number | 62723733 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 02/22/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/30/2014 |
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 |
Treatment | 1IN WIDTH PLATE.PN 00880200100.; 2IN WIDTH PLATE.PN 00880200200.; 3IN WIDTH PLATE.PN 00880200300.; 4IN WIDTH PLATE.PN 00880200400.; DERMATOME SCREWDRIVER.PN 00880300000. |