MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-08-30 for UNKNOWN TED manufactured by Covidien.
[15627133]
It was reported to covidien on (b)(6) 2010 that a customer had an issue with ted stockings. The customer reports the thigh length ted stockings were applied pre-op. Postop the patient was sent to the icu where it was noticed the patient had tissue injury at the site of the elastic band on the top of the thigh. This was on the same day as surgery. Patient's leg was re-measured and correct size confirmed. The stockings were removed and xenoderm applied to wound area.
Patient Sequence No: 1, Text Type: D, B5
[15822710]
Submit date: (b)(4) 2010. An investigation is currently underway; upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017072-2010-00023 |
| MDR Report Key | 1823794 |
| Report Source | 05,06 |
| Date Received | 2010-08-30 |
| Date of Report | 2010-08-05 |
| Date of Event | 2010-06-01 |
| Report Date | 2010-08-05 |
| Date Reported to Mfgr | 2010-08-05 |
| Date Mfgr Received | 2010-08-05 |
| Date Added to Maude | 2011-02-11 |
| 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 | 3 |
| Manufacturer Contact | JUDITH SHAW, RN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 14487 BLUE RIDGE BLVD. |
| Manufacturer City | SENECA SC 29672 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29672 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN TED |
| Generic Name | COMPRESSION STOCKINGS |
| Product Code | DWL |
| Date Received | 2010-08-30 |
| Model Number | UNKNOWN TED |
| Catalog Number | UNKNOWN TED |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 14487 BLUE RIDGE BLVD. SENECA SC 29672 US 29672 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2010-08-30 |