Brand Name | ENDO-FLO |
Type of Device | LAPAROSCOPIC IRRIG SYS |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section F) |
DAVOL, INC. |
100 sockanossett xrd |
cranston RI 02920 |
|
Manufacturer (Section D) |
DAVOL, INC. |
100 sockanossett xrd |
cranston RI 02920 |
|
Manufacturer (Section G) |
DAVOL INC., SUB. C.R. BARD, INC. |
100 sockanossett crossroad |
|
cranston RI 02920 |
|
Device Event Key | 59796 |
MDR Report Key | 59369 |
Event Key | 55799 |
Report Number | 1213643-1996-00044 |
Device Sequence Number | 1 |
Product Code | KQT |
Report Source |
Manufacturer
|
Source Type |
User facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 02/26/1996 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | ZPQNO-STK |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Event Location |
Invalid Data
|
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Is The Device Single Use? |
No Answer Provided
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
|
Type of Device Usage |
Unkown
|
|
|