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 2020-03-09 for ORBERA? INTRAGASTRIC BALLOON SYSTEM manufactured by Apollo Endosurgery, Inc..
[183975439]
Initial medwatch sent to the fda. 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 ", "vomiting", "dehydration", "cramping" and "nausea" as follows: the physiological response of the patient to the presence of the orbera system balloon may vary depending upon the patient's general condition and the level and type of activity. The types and frequency of administration of drugs or diet supplements and the overall diet of the patient may also affect the response. Each patient must be monitored closely during the entire term of treatment in order to detect the development of possible complications. Each patient should be instructed regarding symptoms of deflation, gastrointestinal obstruction, ulceration and other complications which might occur, and should be advised to contact his/her physician immediately upon the onset of such symptoms. Placement of the balloon within the stomach produces a delay in gastric emptying. This can create a variety of expected and predictable reactions including 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 throughout the entire placement duration due to the delay in gastric emptying. Most patients acclimate to the presence of the device within the first 2 weeks. In order to prevent or ameliorate the symptoms most frequently experienced after placement, physicians should prescribe proton pump inhibitors (ppis) and antiemetics prophylactically and consider prescribing temporarily antispasmodics or anticholinergic medications for cramping due to accommodation of the balloon, and/or prokinetic medications for symptoms due to the delay in gastric emptying. Patients should be advised to immediately contact their physician for any unusually severe, worsening, or recurrent symptoms. Complications: possible complications of the use of the orbera system include: gastric discomfort, feelings of nausea and vomiting following balloon placement as the digestive system adjusts to the presence of the balloon. Continuing nausea and vomiting. This could result from direct irritation of the lining of the stomach or as a result of the balloon blocking the outlet of the stomach. It is even theoretically possible that the balloon could prevent vomiting (not nausea or retching) by blocking the inlet to the stomach from the esophagus. Abdominal or back pain, either steady or cyclic.
Patient Sequence No: 1, Text Type: N, H10
[183975440]
Reported as: patient presented bad cramping and pain along with nausea and vomiting. Patient had to go get iv fluids because patient was dehydrated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006722112-2020-00038 |
| MDR Report Key | 9808731 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-09 |
| 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 | DR. DAVID HOOPER |
| Manufacturer Street | 1120 S. CAPITAL OF TEXAS HWY BLDG 1, STE. 300 |
| Manufacturer City | CS |
| Manufacturer Country | US |
| Manufacturer G1 | APOLLO ENDOSURGERY COSTA RICA, SRL |
| Manufacturer Street | COYOL FREE ZONE 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 | ORBERA? INTRAGASTRIC BALLOON SYSTEM |
| Generic Name | INTRAGASTRIC BALLOON |
| Product Code | LTI |
| Date Received | 2020-03-09 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-09 |