Brand Name | LAP BAND |
Type of Device | IMAPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Manufacturer (Section D) |
|
MDR Report Key | 9539927 |
MDR Text Key | 173655187 |
Report Number | MW5091987 |
Device Sequence Number | 1 |
Product Code |
LTI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Patient
|
Type of Report
| Initial |
Report Date |
12/27/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Catalogue Number | RLZB32D |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/31/2019 |
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 47 YR |
Patient Weight | 108 |
|
|