MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for TM6000 manufactured by The Or Company Llc.
[133352772]
During use, the insufflation tubing occluded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8256417 |
| MDR Report Key | 8256417 |
| Date Received | 2019-01-17 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-12-18 |
| Report Date | 2018-12-21 |
| Date Reported to FDA | 2018-12-21 |
| Date Reported to Mfgr | 2019-01-17 |
| Date Added to Maude | 2019-01-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | INSUFFLATOR TUBING SET |
| Product Code | NKC |
| Date Received | 2019-01-17 |
| Catalog Number | TM6000 |
| Lot Number | 1727955 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE OR COMPANY LLC |
| Manufacturer Address | 1625 TACOMA WAY TACOMA WA 98409 US 98409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-17 |