MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-03-26 for STOCKINGS T.E.D. THIGH MED REG 3416LF manufactured by Covidien.
[139918582]
Additional information was requested from the initial reporter but at this time no additional incident or patient details have been provided. The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Patient Sequence No: 1, Text Type: N, H10
[139918583]
The customer reports that they had a situation where this item was used on a patient and amputation occurred due to complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00651 |
| MDR Report Key | 8453963 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-26 |
| Date Mfgr Received | 2019-03-06 |
| Date Added to Maude | 2019-03-26 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | EDIFICIO B20 CALLE #2 ZONA FRA |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STOCKINGS T.E.D. THIGH MED REG |
| Generic Name | STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS) |
| Product Code | DWL |
| Date Received | 2019-03-26 |
| Model Number | 3416LF |
| Catalog Number | 3416LF |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | EDIFICIO B20 CALLE #2 ZONA FRA ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2019-03-26 |