Brand Name | HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR |
Type of Device | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
Manufacturer (Section D) |
DAVOL INC., SUB. C.R. BARD, INC. -1213643 |
100 crossings blvd. |
warwick RI 02886 |
|
Manufacturer (Section G) |
DAVOL SURGICAL INNOVATIONS -9616067 |
ave. roberto fierro #6408 |
parque industrial aeropuerto |
cd. juarez, chih s.a. de c.v. 32690 |
MX
32690
|
|
Manufacturer Contact |
andrew
topoulos
|
100 crossings blvd. |
warwick, RI 02886
|
8005566756
|
|
MDR Report Key | 16612883 |
MDR Text Key | 312031633 |
Report Number | 1213643-2023-00118 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
UDI-Device Identifier | 00801741000362 |
UDI-Public | (01)00801741000362 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K961492 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,User Facility,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
03/08/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 0026870 |
Device Lot Number | JUGS0725 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 03/10/2023 |
Initial Date Manufacturer Received |
03/06/2023 |
Initial Date FDA Received | 03/24/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/09/2022 |
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 |
Patient Outcome(s) |
Other;
|