Brand Name | HOUSE CURRETTE, 17CM OVAL, LG, SPOON 2.2MMX2.5MM |
Type of Device | CURRETTE |
Manufacturer (Section D) |
GYRUS ACMI INC. |
136 turnpike road |
southborough MA 01772 210 |
|
Manufacturer (Section G) |
GYRUS ACMI INC. |
136 turnpike road |
|
southborough MA 01772 210 |
|
Manufacturer Contact |
noemi
schambach
|
2400 ringwood ave |
san jose, CA 95131
|
4089355002
|
|
MDR Report Key | 3829869 |
MDR Text Key | 19587252 |
Report Number | 2951238-2014-00097 |
Device Sequence Number | 1 |
Product Code |
FZS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
02/11/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/11/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 272602 |
Device Catalogue Number | 272602 |
Device Lot Number | 03066142/AL |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 02/11/2014 |
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
|
Patient Sequence Number | 1 |
Treatment | 2951238-2014-00098.; HOUSE CURETTE, PRODUCT# 272602, LOT #03066142/AL, |
|
|