MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-30 for MAESTRO RECHARGEABLE SYSTEM 2002 manufactured by Reshape Life Sciences.
[125466434]
The patient had a vbloc device placed years ago in (b)(6) and has not charged or used the device in years. However, the patient has complained about a "lump growing in the same place as where the vbloc device is implanted. " the patient claims there is potential bleeding as there is a growing bruise and the black and blue area is continuing to spread. The patient reported the affected area is about 6-7 inches and is experiencing sharp pains. It is unknown if the patient has had the vbloc explanted, the patient now lives in (b)(6), reshape lifesciences recommended to the patient to see a physician in the area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005025697-2018-00011 |
| MDR Report Key | 8018997 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-09-24 |
| Date Mfgr Received | 2018-10-02 |
| Date Added to Maude | 2018-10-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KRISTIN WIELENGA |
| Manufacturer Street | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer G1 | RESHAPE LIFE SCIENCES |
| Manufacturer Street | 2800 PATTON ROAD |
| Manufacturer City | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAESTRO RECHARGEABLE SYSTEM |
| Generic Name | RECHARGEBALE NEUROREGULATOR |
| Product Code | PIM |
| Date Received | 2018-10-30 |
| Model Number | 2002 |
| Catalog Number | 2002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESHAPE LIFE SCIENCES |
| Manufacturer Address | 2800 PATTON ROAD SAINT PAUL MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-30 |