MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-06 for I-GEL 8204000 manufactured by Intersurgical Uab.
[166982058]
A visual, dimensional, and functional inspection of the device involved in this complaint could not be conducted since the device was not returned. A device history record review could not be conducted since the lot number was not provided. Per the anesthesiologist the i-gel went in normally and the procedure was successfully completed. It was noted in the reporting that the device was positioned on the patient's chest and lubricated on the back side of the device. Per the ifu the cuff should be lubricated on the back, sides and front of the cuff. The cuff should always be placed back into the cradle during preparation and prior to use. Per the warnings do not place onto the chest or pillow of patient, always use protective cradle/cage pack provided. It is undetermined how the introduction of the "ekg backing" was to the patient. Per the ifu pre-use check it is essential to inspect the device for damage, foreign bodies or bolus of lubricant. This includes inside the bowl to ensure the surface are smooth and intact.
Patient Sequence No: 1, Text Type: N, H10
[166982059]
The patient reported symptoms of gagging and difficulty swallowing. This occurred 3-4 hours after procedure. The patient reached into his throat and pulled out a piece of plastic. It was transparent with blue lines and determined to be an ekg backing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319447-2019-00001 |
| MDR Report Key | 9284664 |
| Date Received | 2019-11-06 |
| Date of Report | 2019-10-31 |
| Date of Event | 2019-10-03 |
| Date Added to Maude | 2019-11-06 |
| 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 | MR. IVAN SENIUT |
| Manufacturer Street | ARNIONIU 60/28-1 |
| Manufacturer City | PABRADE, VILNIAUS APSKRITIS, LT-4710 |
| Manufacturer Country | LH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-GEL |
| Generic Name | AIRWAY, OROPHARYNGEAL |
| Product Code | CAE |
| Date Received | 2019-11-06 |
| Model Number | 8204000 |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERSURGICAL UAB |
| Manufacturer Address | ARNIONIU 60/28-1 PABRADE, LH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-06 |