MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-10-16 for T.E.D. 7115 manufactured by Covidien.
[123896458]
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[123896459]
The customer reports the patient received a diagnosis of peroneal nerve paralysis after using scd and ted products.
Patient Sequence No: 1, Text Type: D, B5
[132591362]
(b)(6) 2018 an investigation was performed for the reported customer complaint: the customer reports the patient received a diagnosis of peroneal nerve paralysis after using scd and ted products. No lot number was provided. A review of the device history record (dhr) was unable to be performed. However, all dhrs are reviewed for accuracy prior to product release. In-process procedures are also in place to prevent nonconforming product in the manufacturing process. This ensures components and finished products meet all quality inspection standards. 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. Additional information was received from the customer regarding the condition of the patient. The patient was in the hospital for a scheduled surgery. The patient? S stay was extended due to the reported event. However, the length of the extension was indicated as unknown. Medical intervention was reported as removal of the scd sleeve and ted stocking, with follow up consisting of observation only. It was reported that the patient has recovered and was discharged from the hospital. No further patient information was provided. No product/sample was provided for evaluation. No additional information, pictures or videos were received. Therefore, a comprehen sive 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 used 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 | 3009211636-2018-00328 |
| MDR Report Key | 7971440 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-10-16 |
| Date of Report | 2018-12-31 |
| Date of Event | 2018-04-25 |
| Date Mfgr Received | 2018-09-19 |
| Date Added to Maude | 2018-10-16 |
| 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 | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T.E.D. |
| Generic Name | STOCKING, MEDICAL SUPPORT (TO PREVENT POOLING OF BLOOD IN LEGS) |
| Product Code | DWL |
| Date Received | 2018-10-16 |
| Model Number | 7115 |
| Catalog Number | 7115 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | EDIFICIO B20, CALLE #2 ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-16 |