MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1999-10-29 for DEROYAL 9006-00 manufactured by Deroyal Industries, Inc..
[184543]
Pt had surgery on left shoulder. Following surgery, he was fitted with an arm sling and swath. Three to four days following the surgery, he noticed a rash and hives around his left arm and back. The pt required treatment with antihistamines for a period of 10 days in order for the rash and hives to clear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1123835-1999-00001 |
| MDR Report Key | 247947 |
| Report Source | 04 |
| Date Received | 1999-10-29 |
| Date of Report | 1999-10-28 |
| Date of Event | 1999-09-26 |
| Date Facility Aware | 1999-09-26 |
| Report Date | 1999-10-28 |
| Date Reported to FDA | 1999-10-28 |
| Date Added to Maude | 1999-11-04 |
| 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 | 4239387828 |
| 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 | DEROYAL |
| Generic Name | ARM SLING AND SWATH |
| Product Code | ILI |
| Date Received | 1999-10-29 |
| Model Number | NA |
| Catalog Number | 9006-00 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 240208 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | DEROYAL |
| Baseline Generic Name | ARM SLING & SWATH |
| Baseline Model No | NA |
| Baseline Catalog No | 9006-00 |
| Baseline ID | NA |
| Baseline Device Family | SLING, ARM |
| 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 | 1999-10-29 |