MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-03-31 for UNKNOWN TEDS manufactured by Covidien.
[4221055]
It was reported to covidien on (b)(6) 2014 that a customer had an issue with an unk ted stocking. The customer states that pt was wearing ted stockings and slipped on the linoleum floor in her bathroom. The pt was taken to (b)(6) for hospitalization. She was bruised all over and had muscle inflammation. Additional information was not provided.
Patient Sequence No: 1, Text Type: D, B5
[11909403]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009211636-2014-00003 |
| MDR Report Key | 3736625 |
| Report Source | 01,08 |
| Date Received | 2014-03-31 |
| Date of Report | 2014-03-21 |
| Date of Event | 2014-03-21 |
| Date Mfgr Received | 2014-03-21 |
| Date Added to Maude | 2014-05-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAWRENCE ROCK |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616625 |
| Manufacturer G1 | COVIDIEN MANUFACTURING SOLULFONS SA |
| Manufacturer Street | EDIFICIO 820 CALLE #2 ZONA FRANCA |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN TEDS |
| Generic Name | UNKNOWN TEDS |
| Product Code | DWL |
| Date Received | 2014-03-31 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | COVIDIEN MANUFACTURING ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-03-31 |