MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-05-15 for 4442-00 COOL BLUE SLING/SWATHE UNIV manufactured by Deroyal Industries, Inc..
[247210]
Patient developed red itchy rash on the right forearm where the foam lining of a sling and swathe is touching the skin. The rash was noticed by the nurse. This pt is transferred today from the hospital to the rehab hospital the device was put on the patient at the hospital. The product is described as deep blue perforated material with cream colored foam lining, and has tentatively been identified as 4442-00. Minx check of labeling for this product number indicated that it contains natural rubber latex. This information was given to the nurse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2320947-2002-00001 |
| MDR Report Key | 395362 |
| Report Source | 06 |
| Date Received | 2002-05-15 |
| Date of Report | 2002-05-14 |
| Date of Event | 2002-04-19 |
| Date Facility Aware | 2002-04-19 |
| Report Date | 2002-04-22 |
| Date Mfgr Received | 2002-04-22 |
| Date Added to Maude | 2002-05-23 |
| 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 | 4442-00 COOL BLUE SLING/SWATHE UNIV |
| Generic Name | TLH TOP-OF-THE-LINE SHOULDER PRODS |
| Product Code | ILI |
| Date Received | 2002-05-15 |
| Model Number | NA |
| Catalog Number | 4442-00 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | UNKNOWN |
| 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 | 384369 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | 4442-00 COOL BLUE SLING/SWATHE UNIV |
| Baseline Generic Name | TLH TOP-OF-THE-LINE SHOULDER PRODS |
| Baseline Model No | NA |
| Baseline Catalog No | 4442-00 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-05-15 |