MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-28 for CHATTANOOGA 2026 manufactured by Lpg Systems.
[41304712]
Complaint received that alleges "during treatment patient's 4th digit on their left hand was entrapped between the joint of the optiflex k1 extension arm. The machine stopped but did not release the patient's finger. The staff had to use tools to manually release the patient's finger. Warranty. Injuries sustained: redness, swelling, bruising". Questionnaire not received from clinician and/or patient. Device not returned to manufacturer for evaluation. No indication event caused or contributed to permanent impairment or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020737-2016-00003 |
| MDR Report Key | 5529887 |
| Date Received | 2016-03-28 |
| Date of Report | 2016-09-28 |
| Date of Event | 2016-03-18 |
| Date Facility Aware | 2016-03-18 |
| Report Date | 2016-03-28 |
| Date Reported to FDA | 2016-03-28 |
| Date Reported to Mfgr | 2016-03-28 |
| Date Added to Maude | 2016-03-28 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 City | CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHATTANOOGA |
| Generic Name | OPTIFLEX ?K1 |
| Product Code | BXB |
| Date Received | 2016-03-28 |
| Model Number | 2026 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LPG SYSTEMS |
| Manufacturer Address | 30 RUE DU DOCTEUR ABEL VALENCE DROME, FRANCE CA 26902 US 26902 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-28 |