MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-12-13 for ETHOX 950095903 manufactured by Ethox Llc..
[95740856]
The affected device was not returned by the customer, but they did provide a lot number and a photo of the device after usage. An inventory evaluation was performed on current product in inventory. The q. E. Visually inspected 8 devices. The inspected devices did not show any abnormalities. The investigator's conclusion is that the affected device could not have possibly been produced or shipped in the condition depicted in photo supplied by customer. In addition, the practitioner could not have possibly inserted the device in this condition. The device could only have become knotted in the patient's stomach. Re-creation of the incident could not be performed due to many variables. The investigator's conclusion is that the tube was over-inserted into the patient causing it to form a knot. The affected device was shipped with an ifu instructing the user to insert the tube per the approved standard hospital procedure. The investigator's conclusion is that the incident in question was the result of improper usage of the device. There is no indication that the product was defective. There is no record of any previous incidents like the one in question.
Patient Sequence No: 1, Text Type: N, H10
[95740857]
The customer alleges that "the lavage tubing was in a knot when pulled from the patient. " no other details were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1314417-2017-00004 |
| MDR Report Key | 7113695 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-12-13 |
| Date of Report | 2017-11-27 |
| Date Added to Maude | 2017-12-13 |
| 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 | MS. CARRIE FORTUNA |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal | 49544 |
| Manufacturer Phone | 6162598400 |
| Manufacturer G1 | ETHOX LLC. |
| Manufacturer Street | 2710 NORTHRIDGE DR. SUITE A |
| Manufacturer City | GRAND RAPIDS MI 49544 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETHOX |
| Generic Name | GASTRIC LAVAGE |
| Product Code | KDH |
| Date Received | 2017-12-13 |
| Model Number | 950095903 |
| Lot Number | 308337 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHOX LLC. |
| Manufacturer Address | 2710 NORTHRIDGE DR. SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-13 |