MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-01 for 90043086 30210 FOOT PROTECTOR X72 31143178 manufactured by Tridien Medical.
[37302362]
Submit date: 02/01/2016. Submit date:an investigation is currently under way. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[37302363]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a foot protector. The customer reports: the patient had devon boots for pressure relief yet we find her with skin discolouration on her feet. Subsequently the patient developed a stage 3 ulcer on her foot.
Patient Sequence No: 1, Text Type: D, B5
[43544531]
A device history record review could not be performed because a lot number was not received with the complaint. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. There were no physical samples received with this complaint therefore an examination of the samples could not be made to confirm the reported issue and determine the root cause. A photo was provided showing the patients skin condition; however, it is unclear from the photo if there are any issues with the product itself. It should be noted that this product is intended to be used during surgery. Per the details in the complaint, the product was in use for 3 days, this may be a possible root cause. It would be advised that a heel off loading device be used for long term support. No corrective or preventive actions will be taken at this time. If additional information is received the investigation will resume as needed. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2016-00014 |
| MDR Report Key | 5402522 |
| Date Received | 2016-02-01 |
| Date of Report | 2016-02-01 |
| Date Mfgr Received | 2016-04-25 |
| Date Added to Maude | 2016-02-01 |
| 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 | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 90043086 30210 FOOT PROTECTOR X72 |
| Generic Name | DEVON BOOT |
| Product Code | FMP |
| Date Received | 2016-02-01 |
| Model Number | 31143178 |
| Catalog Number | 31143178 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRIDIEN MEDICAL |
| Manufacturer Address | 1691 NORTH DELILAH STREET CORONA CA 92879 US 92879 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-01 |