MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-25 for WEIGHTRIGHT MERCURY-FREE 1208-52 manufactured by Medovations Inc..
[26738312]
Patient Sequence No: 1, Text Type: N, H10
[26738313]
When the nurse and tech went to the shelf they noticed the bougie tubes had a lot number and date that seemed to be put on the tubes with a marker instead of being stamped on. Hard to tell. Items were expiring and rep told the operating room staff not to use them since they were expiring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5103678 |
| MDR Report Key | 5103678 |
| Date Received | 2015-09-25 |
| Date of Report | 2015-09-18 |
| Date of Event | 2015-09-08 |
| Report Date | 2015-09-18 |
| Date Reported to FDA | 2015-09-18 |
| Date Reported to Mfgr | 2015-09-18 |
| Date Added to Maude | 2015-09-25 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 102 East Keefe Ave. |
| Manufacturer City | Milwaukee WI 53212 |
| Manufacturer Country | US |
| Manufacturer Postal | 53212 |
| Manufacturer Phone | 265-7620 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WEIGHTRIGHT MERCURY-FREE |
| Generic Name | BOUGIE, ESOPHAGEAL, AND GASTROINTESTINAL, GASTRO-UROLOGY |
| Product Code | FAT |
| Date Received | 2015-09-25 |
| Model Number | 1208-52 |
| Catalog Number | 1208-52 |
| Lot Number | 213676 |
| Device Expiration Date | 2015-09-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOVATIONS INC. |
| Manufacturer Address | 102 EAST KEEFE AVENUE MILWAUKEE WI 53212 US 53212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-25 |