MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-25 for CURITY 3033 manufactured by Covidien Llc.
[73572423]
Patient Sequence No: 1, Text Type: N, H10
[73572424]
Needed gauze for a patient's wound and opened a new box of curity gauze sponges to find one was opened and empty and the other had a broken bottom seal, compromising the integrity of the gauze sponge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6518023 |
| MDR Report Key | 6518023 |
| Date Received | 2017-04-25 |
| Date of Report | 2017-04-17 |
| Date of Event | 2017-04-16 |
| Report Date | 2017-04-17 |
| Date Reported to FDA | 2017-04-17 |
| Date Reported to Mfgr | 2017-04-17 |
| Date Added to Maude | 2017-04-25 |
| 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 |
| 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 |
| Brand Name | CURITY |
| Generic Name | GAUZE SPONGE |
| Product Code | FRL |
| Date Received | 2017-04-25 |
| Catalog Number | 3033 |
| Lot Number | 16J181662 |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-25 |