MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-06 for LAP-BAND SYSTEM NI manufactured by Reshape Lifesciences.
| Report Number | 3013508647-2020-00006 |
| MDR Report Key | 9677458 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-09-12 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KRISTIN WIELENGA |
| Manufacturer Street | 1001 CALLE AMANECER |
| Manufacturer City | SAN CLEMENTE CA 92673 |
| Manufacturer Country | US |
| Manufacturer Postal | 92673 |
| Manufacturer G1 | APOLLO ENDOSURGERY |
| Manufacturer Street | BUILDING B 13.3 |
| Manufacturer City | ALAJUELA, CS |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LAP-BAND SYSTEM |
| Generic Name | ADJUSTABLE GASTRIC BAND |
| Product Code | LTI |
| Date Received | 2020-02-06 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESHAPE LIFESCIENCES |
| Manufacturer Address | 1001 CALLE AMANECER SAN CLEMENTE CA 92673 US 92673 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-06 |