MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-05-29 for SL8001-05 SAMSON MEDIUM manufactured by Deroyal Industries, Inc..
[270425]
The pt broke out in painful blisters that became shiny and red after wearing the walker for one week. Now the whole leg is split and/or cracked open in places pt's dr prescribed an ointment yesterday. Pt is also diabetic. Pt wants to know the material make-up of the device. The product number may be incorrect. It was determined by the description of the product given to staff person by the pt. Replacement of b-product and 1 roll stockinette will be sent overnight. Ups will pick up product for return to the co.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1122762-2002-00003 |
| MDR Report Key | 397873 |
| Report Source | 00 |
| Date Received | 2002-05-29 |
| Date of Report | 2002-05-24 |
| Date of Event | 2002-04-24 |
| Report Date | 2002-04-24 |
| Date Mfgr Received | 2002-04-24 |
| Date Added to Maude | 2002-06-06 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SL8001-05 SAMSON MEDIUM |
| Generic Name | TDA THREE-D FOOT PRODUCTS |
| Product Code | ISH |
| Date Received | 2002-05-29 |
| Model Number | NA |
| Catalog Number | SL8001-05 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 386920 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | DEROYAL |
| Baseline Generic Name | FOOT ORTHOTIC |
| Baseline Model No | NA |
| Baseline Catalog No | SL8001-05 |
| Baseline ID | NA |
| Baseline Device Family | VARIOUS TYPES OF WALKERS |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-05-29 |