Brand Name | DERMATOME BLADES |
Type of Device | DERMATOME BLADE, SINGLE-USE |
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 | 18431187 |
MDR Text Key | 331815038 |
Report Number | 0001526350-2024-00004 |
Device Sequence Number | 1 |
Product Code |
GFD
|
UDI-Device Identifier | 00889024375895 |
UDI-Public | (01)00889024375895(17)280205(10)65599469 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Health Professional |
Reporter Occupation |
Nurse
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
01/02/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/02/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 00880000010 |
Device Lot Number | 65599469 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 12/04/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | ZFA 2023-00208 |
Patient Sequence Number | 1 |
Treatment | UNK BLADE; UNK BLADE |
Patient Outcome(s) |
Other;
|
Patient Sex | Prefer Not To Disclose |