MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-22 for * TM-6000 manufactured by Josnoe Medical, Inc.
[3326636]
Insufflating tubing clogged and staff was unable to insufflate the abdomen. What was the original intended procedure? Lapband removal. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3036075 |
| MDR Report Key | 3036075 |
| Date Received | 2013-02-22 |
| Date of Report | 2013-02-22 |
| Date of Event | 2013-02-21 |
| Report Date | 2013-02-22 |
| Date Reported to FDA | 2013-02-22 |
| Date Reported to Mfgr | 2013-04-04 |
| Date Added to Maude | 2013-04-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | TUBING |
| Product Code | NKC |
| Date Received | 2013-02-22 |
| Model Number | * |
| Catalog Number | TM-6000 |
| Lot Number | B128919 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOSNOE MEDICAL, INC |
| Manufacturer Address | 2442 MCKINLEY RD. CHELSEA MI 48118 US 48118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-22 |