MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,user facility report with the FDA on 2020-02-26 for SITUATE 01-0043 manufactured by Covidien Mfg Dc Boulder.
[181659095]
This product is not sold in us and is 510(k) exempt. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[181659096]
According to the reporter, when the device was used to scan for sponges, the scanner kept on reading positive 2 times. They took 2 x-rays and it showed that there was no sponges. They tried 4 more times with the scanner and the result was clear each time, showing there was no sponges.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717344-2020-00192 |
| MDR Report Key | 9753583 |
| Report Source | CONSUMER,USER FACILITY |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-28 |
| Date Mfgr Received | 2020-01-31 |
| Date Added to Maude | 2020-02-26 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MFG DC BOULDER |
| Manufacturer Street | 5920 LONGBOW DR |
| Manufacturer City | BOULDER CO 803013299 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 803013299 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SITUATE |
| Generic Name | COUNTER, SPONGE, SURGICAL |
| Product Code | LWH |
| Date Received | 2020-02-26 |
| Model Number | 01-0043 |
| Catalog Number | 01-0043 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG DC BOULDER |
| Manufacturer Address | 5920 LONGBOW DR BOULDER CO 803013299 US 803013299 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-26 |