MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-02 for DEVON 31143384 manufactured by Covidien.
[115796917]
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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[115796918]
Customer reports: the patient presented a small, dry, red (granulating) wound on the anterior of the shin that was covered with a dry dressing. The community nurses used a devon utility pad folded over between the legs to relive some pressure from the area. Within three days the wound over doubled in size and since then has continued to deteriorate and is now down to tendon.
Patient Sequence No: 1, Text Type: D, B5
[134100505]
No lot number was provided. A review of the device history report (dhr) was unable to be performed. However, all dhrs are reviewed for accuracy prior to product release. In-process procedures are in place to prevent nonconforming product in the manufacturing process. These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification. Since no lot number provided, a date of manufacture could not be determined. This product was being used for treatment or diagnosis. Customer provided information also relayed that the nurses say they have now turned the devon pad around using the flat surface against the skin. Employees have reiterated they don? T encourage this as it is incorrect use and it should be considered removing the pad and finding an alternative. The device was folded over and utilized in a non-conventional method. Standard wound care would not place pressure on a wound. Wounds are typically identified and documented with each visit. Changes to the wound care and appropriate measures should be implemented. No product/sample was provided for evaluation. No additional information, pictures or videos were received. Therefore, a comprehensive investigation was unable to be conducted. The reported customer complaint could not be confirmed. A root cause could not be determined. This complaint will be utilized for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2018-00640 |
| MDR Report Key | 7742412 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-02 |
| Date of Report | 2019-01-25 |
| Date of Event | 2018-04-06 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-08-02 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 15 HAMPSHIRE ST |
| 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 | DEVON |
| Generic Name | SUPPORT, PATIENT POSITION |
| Product Code | CCX |
| Date Received | 2018-08-02 |
| Model Number | 31143384 |
| Catalog Number | 31143384 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-02 |