MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-09-19 for UNKNOWN TEDS manufactured by Costa Rica.
[4760255]
It was reported to covidien on (b)(6) 2014 that a customer had an issue with an unknown ted stocking. The customer states that the patient developed an ingrown toenail and infection to the left big toe after wearing the compression stockings post lumber surgery. No additional information provided related to treatment.
Patient Sequence No: 1, Text Type: D, B5
[12172641]
Submit date: (b)(6) 2014. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[31481252]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[31481253]
This complaint has not been confirmed. The complaint sample was not returned to the manufacturing site for review. The manufacturing lot number associated with this complaint was not provided. Without the lot number, a dhr review could not be performed. All dhrs are reviewed for accuracy prior to product release. Without the sample and lot number, it is not possible to determine a confirmed root cause of this issue. Should the sample be returned in the future, this complaint will be re-opened for further investigation. It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations. A capa is not deemed necessary at this time. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2014-00083 |
| MDR Report Key | 4101032 |
| Report Source | * |
| Date Received | 2014-09-19 |
| Date of Report | 2014-08-27 |
| Date of Event | 2014-03-12 |
| Date Mfgr Received | 2014-09-25 |
| Date Added to Maude | 2014-09-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAWRENCE ROCK |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616625 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN TEDS |
| Generic Name | TED STOCKING |
| Product Code | FQL |
| Date Received | 2014-09-19 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COSTA RICA |
| Manufacturer Address | COVIDIEN MANUFACTURING SOLULFONS SA EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-19 |