MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-08-31 for 800023 manufactured by Given Imaging Los Angeles Llc.
[119505423]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[119505424]
The following article investigated the effectiveness of peroral endoscopic myotomy (poem) surgery in achalasia patients with failure of prior pneumatic dilation (pd). Twenty-one patients with a history of failed pd were prospectively recruited as the case group, and 30 patients with no history of prior treatment for achalasia were included as the control group. Complications that occurred during the surgery included three cases of subcutaneous emphysema and one case of pneumothorax. At 3 months after peroral endoscopic myotomy (poem), four patients reported heartburn and regurgitation and were subsequently confirmed to have esophagitis through esophagogastroduodenoscopy (egd).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005344223-2018-00009 |
| MDR Report Key | 7839270 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-31 |
| Date of Event | 2014-02-21 |
| Date Mfgr Received | 2018-08-03 |
| Date Added to Maude | 2018-08-31 |
| 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 | AMY BEEMAN |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | GIVEN IMAGING LOS ANGELES LLC |
| Manufacturer Street | 5860 UPLANDER WAY |
| Manufacturer City | CULVER CITY CA 90230 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90230 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
| Product Code | FFX |
| Date Received | 2018-08-31 |
| Model Number | 800023 |
| Catalog Number | 800023 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LOS ANGELES LLC |
| Manufacturer Address | 5860 UPLANDER WAY CULVER CITY CA 90230 US 90230 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-31 |