MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-17 for CAP ANTI-EMBOLISM STOCKINGS manufactured by Carolon Co..
[67677033]
Patient Sequence No: 1, Text Type: N, H10
[67677034]
The rn obtained support stockings from the supply room. When in the room while opening the package the nurse noticed the stockings were moldy. The nurse returned to the supply room and noted all of the stockings in the same condition. The materials checked the lot number and removed all items with this lot number. Unfortunately, materials discarded the items instead of returning to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6338689 |
| MDR Report Key | 6338689 |
| Date Received | 2017-02-17 |
| Date of Report | 2017-02-09 |
| Date of Event | 2017-01-18 |
| Report Date | 2017-02-09 |
| Date Reported to FDA | 2017-02-09 |
| Date Reported to Mfgr | 2017-02-09 |
| Date Added to Maude | 2017-02-17 |
| 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 | CAP ANTI-EMBOLISM STOCKINGS |
| Generic Name | STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS) |
| Product Code | DWL |
| Date Received | 2017-02-17 |
| Lot Number | 288 16 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAROLON CO. |
| Manufacturer Address | 601 FORUM PARKWAY RURAL HALL NC 27045 US 27045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-17 |