MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-10-04 for KNEE LENGTH MED/REG TED 7115 manufactured by Covidien Manufacturing Solulfons Sa.
[3918082]
It was reported to covidien on (b)(6) 2013 that a customer had an issue with a compression stocking. The customer states an elderly patient had developed stage three pressure ulcers. The charge nurse manager indicates the ted stocking as the cause of the stage 3 pressure areas/injuries (claiming correct measurements were completed) due to stockings resting behind the knee. Corrective action taken relevant to the care of the patient: ted stockings were pulled down from pressure area. The patient died from other co-morbidities. There is no additional information available.
Patient Sequence No: 1, Text Type: D, B5
[11162690]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009211636-2013-00003 |
| MDR Report Key | 3410931 |
| Report Source | 01,05,06 |
| Date Received | 2013-10-04 |
| Date of Report | 2013-09-09 |
| Date of Event | 2013-09-09 |
| Date Facility Aware | 2013-09-09 |
| Report Date | 2013-09-09 |
| Date Reported to Mfgr | 2013-09-09 |
| Date Mfgr Received | 2013-09-09 |
| Date Added to Maude | 2013-11-12 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN MANUFACTURING SOLULFONS SA |
| Manufacturer Street | EDIFICIO 820 CALLE 2 ZONA FRANCA COYOL |
| 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 | KNEE LENGTH MED/REG TED |
| Generic Name | COMPRESSION STOCKING |
| Product Code | DWL |
| Date Received | 2013-10-04 |
| Model Number | 7115 |
| Catalog Number | 7115 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MANUFACTURING SOLULFONS SA |
| Manufacturer Address | ALAJUELA 20101 CS 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-04 |