MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-06-05 for 9006-00 CUTAWAY SLING & SWATHE UNIV manufactured by Deroyal Industries, Inc..
[16279424]
The doctor called in this complaint after receiving a call from a patient wearing a swing and swathe device. The patient complained of running eyes, rash and swelling which was attributed to product. The patient's room was clearly labeled "no latex" and the doctor is sure the product contains latex, and that the patient is having a typical latex allergy reaction. A picture of the device was faxed to confirm the product number. Replacement sent 9020-02. The patient will not return the device and will offer no other information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1123835-2001-00002 |
| MDR Report Key | 336733 |
| Report Source | 05 |
| Date Received | 2001-06-05 |
| Date of Report | 2001-05-03 |
| Date of Event | 2001-05-01 |
| Report Date | 2001-05-29 |
| Date Mfgr Received | 2001-05-03 |
| Date Added to Maude | 2001-06-13 |
| 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 | P0WELL 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 | 9006-00 CUTAWAY SLING & SWATHE UNIV |
| Generic Name | TLH TOP-OF-THE-LINE SHOULDER PRODS |
| Product Code | ILI |
| Date Received | 2001-06-05 |
| Model Number | NA |
| Catalog Number | 9006-00 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 326028 |
| 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 | 2001-06-05 |