MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-04-15 for 13982000 AB BNDR 12" UNIV 46-62 manufactured by Deroyal Industries, Inc..
[263993]
Binder has caused a rash on the patient's skin in all areas where the binder contacted the skin. Blisters developed. This was put on the patient following neuro surgery. The hospital thinks this product is labeled latex safe but the box has been destroyed and therefore the lot number and latex information is not available. Patient was given hydrocortizone and benadryl, the binder was removed and a different binder placed on the patient prior to discharge from the hospital. The binder used on the patient has been returned to company.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037420-2002-00001 |
| MDR Report Key | 389435 |
| Report Source | 07 |
| Date Received | 2002-04-15 |
| Date of Report | 2002-04-10 |
| Date of Event | 2002-03-05 |
| Date Facility Aware | 2002-03-05 |
| Report Date | 2002-03-14 |
| Date Mfgr Received | 2002-03-14 |
| Date Added to Maude | 2002-04-24 |
| 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 | 3 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 13982000 AB BNDR 12" UNIV 46-62 |
| Generic Name | DBG DEBQL CHEST PRODUCTS |
| Product Code | FSD |
| Date Received | 2002-04-15 |
| Model Number | NA |
| Catalog Number | 13982000 |
| Lot Number | NOT AVAILABLE |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 378483 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | DEROYAL |
| Baseline Generic Name | BINDER, ABDOMINAL |
| Baseline Model No | NA |
| Baseline Catalog No | 13982000 |
| Baseline ID | NA |
| Baseline Device Family | DBG DEBQL CHEST PRODUCTS |
| 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 | 2002-04-15 |