Brand Name | FLAT DECK 36" WIDE W/O X-RAY |
Type of Device | BED, FLOTATION THERAPY, POWERED |
Manufacturer (Section D) |
HILL-ROM MEXICO |
ave.del telefono no. 200 col. huinala |
apodaca, nuevo leon 66640 |
MX 66640 |
|
Manufacturer Contact |
estephania
cardenas
|
1069 state route 46 east |
batesville, IN 47006
|
8129310130
|
|
MDR Report Key | 18251213 |
MDR Text Key | 330571348 |
Report Number | 3006697241-2023-00131 |
Device Sequence Number | 1 |
Product Code |
IOQ
|
UDI-Device Identifier | 00887761977884 |
UDI-Public | 010088776197788411210909 |
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,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/01/2023 |
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 Model Number | P7924A03 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/17/2023 |
Initial Date FDA Received | 12/01/2023 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/08/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|