MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-06 for LAP-BAND SYSTEM NI manufactured by Reshape Lifesciences.
[178018275]
Allergan lap-band slipped, creating a blockage in the esophagus. The patient could not swallow anything, there was no fluid in the band at that time so no adjustment could be made to manipulate the band. The patient was admitted to the hospital and had to undergo emergency surgery to remove it at full cost. The removal procedure was not covered by insurance. The surgeon said removal could not wait as the band could perforate the stomach, which is life-threatening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013508647-2020-00008 |
| MDR Report Key | 9677771 |
| Report Source | OTHER |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2013-04-15 |
| Date Mfgr Received | 2020-01-23 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 |