MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-12 for T.E.D. STOCKINGS manufactured by Covidien.
[86151396]
Sizing chart incorrect on packaging/ potential chance mis - sizing with possible strangulation of limbs. Same product has two different sizing charts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072123 |
| MDR Report Key | 6861542 |
| Date Received | 2017-09-12 |
| Date of Report | 2017-09-11 |
| Date Added to Maude | 2017-09-13 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| 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 | 0 |
| Brand Name | T.E.D. STOCKINGS |
| Generic Name | STOCKING, MEDICAL SUPPORT |
| Product Code | DWL |
| Date Received | 2017-09-12 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-12 |