Brand Name | THE LINX REFLUX MANAGEMENT SYSTEM |
Type of Device | LAPAROSCOPIC ACCESSORIES, ESOPHAGEAL SIZING |
Manufacturer (Section D) |
ETHICON, JOHNSON & JOHNSON SURGICAL TECHNOLOGIES / ETHICON ENDO-SURGERY, INC. |
|
|
MDR Report Key | 15121622 |
MDR Text Key | 296874468 |
Report Number | MW5111159 |
Device Sequence Number | 1 |
Product Code |
QJN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
07/26/2022 |
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
|
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/27/2022 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 07/27/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 79 YR |
Patient Sex | Female |
Patient Weight | 70 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | Black Or African American |
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