MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-05 for CURITY 2236 manufactured by Covidien Llc.
[56510061]
Patient Sequence No: 1, Text Type: N, H10
[56510062]
A wound care nurse noticed some foreign matter inside the packaging of 4" curity stretch bandage before it was opened. Wound care forwarded the unused bandage to materials.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5999426 |
| MDR Report Key | 5999426 |
| Date Received | 2016-10-05 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-09-08 |
| Report Date | 2016-09-12 |
| Date Reported to FDA | 2016-09-12 |
| Date Reported to Mfgr | 2016-09-12 |
| Date Added to Maude | 2016-10-05 |
| 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 | BANDAGE, ELASTIC |
| Product Code | FQM |
| Date Received | 2016-10-05 |
| Model Number | 2236 |
| Catalog Number | 2236 |
| Lot Number | 16F118562 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-10-05 |