MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-01-27 for ORBERA? INTRAGASTRIC BALLOON SYSTEM B-4800 manufactured by Apollo Endosurgery, Inc..
[179545952]
Initial medwatch submitted to the fda on 27/jan/2020. A review of the device labeling notes the following: the current orbera? Intragastric balloon system directions for use (dfu) addresses the known and anticipated potential events of "pain " as follows: precautions: antiemetics, antispasmodic, and anticholinergic drugs may be prescribed to lessen the early placement symptoms such as nausea, vomiting, and abdominal pain. Patients will need to immediately contact their physician for any severe or unusual symptoms. Placement of the balloon within the stomach produces an expected and predictable reaction characterized most commonly by a feeling of heaviness in the abdomen, nausea and vomiting, gastroesophageal reflux, belching, esophagitis, heartburn, diarrhea and, at times, abdominal, back or epigastric pain and cramping. Food digestion may be slowed during this adjustment period. These symptoms can be treated with antiemetic, antispasmodic, and anticholinergic medications. Typically the stomach acclimates to the presence of the device within the first 2 weeks. In order to prevent or ameliorate the symptoms most frequently experienced during the adjustment period, it is recommended that the physician use proton pump inhibitors (ppis), antiemetics, antispasmodics, and anticholinergic medications prophylactically (before orbera? Placement). Patients should be advised to immediately contact their physician for any unusually severe or worsening symptoms. Abdominal or back pain, either steady or cyclic. Injury to the lining of the digestive tract as a result of direct contact with the balloon, grasping forceps, or as a result of increased acid production by the stomach. This could lead to ulcer formation with pain, bleeding or even perforation. Surgery could be necessary to correct this condition.
Patient Sequence No: 1, Text Type: N, H10
[179545953]
Reported as: "[the patient] was admitted to the er [due to] severe stomach pain [due to] binge eating. "
Patient Sequence No: 1, Text Type: D, B5
[182483303]
Supplement #1 - medwatch submitted to the fda on 3/mar/2020.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006722112-2020-00011 |
| MDR Report Key | 9634695 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-01-27 |
| Date of Report | 2020-02-03 |
| Date of Event | 2019-12-29 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2019-05-31 |
| Date Added to Maude | 2020-01-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. DAVID HOOPER |
| Manufacturer Street | 1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300 |
| Manufacturer City | AUSTIN TX 78746 |
| Manufacturer Country | US |
| Manufacturer Postal | 78746 |
| Manufacturer Phone | 5126194855 |
| Manufacturer G1 | APOLLO ENDOSURGERY COSTA RICA, SRL |
| Manufacturer Street | COYOL FREE ZONE BUILDING B 13.3 |
| Manufacturer City | ALAJUELA, |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORBERA? INTRAGASTRIC BALLOON SYSTEM |
| Generic Name | INTRAGASTRIC BALLOON |
| Product Code | LTI |
| Date Received | 2020-01-27 |
| Model Number | B-4800 |
| Catalog Number | B-4800 |
| Lot Number | AF02865 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APOLLO ENDOSURGERY, INC. |
| Manufacturer Address | 1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300 AUSTIN TX 78746 US 78746 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-27 |