MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2002-05-15 for 21903 ARM SLING W/SWATHE - LARGE manufactured by Deroyal Industries, Inc..
[15256803]
While wearing the armsling, the patient developed a rash all around the neck area. Patient reported having a history of a latex / adhesive allergy. Patient is currently wearing a scarf around neck to keep the strap from touching their neck. Patient also mentioned that arm doesn't stay put very well in the arm pocket area. Company staff person ordered a 9014-00 and a tx9905-03 to be sent next day air as replacements. Ups will pick up the original arm sling and return it to the company.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037420-2002-00005 |
| MDR Report Key | 402191 |
| Report Source | 04 |
| Date Received | 2002-05-15 |
| Date of Report | 2002-05-07 |
| Date of Event | 2002-04-10 |
| Date Mfgr Received | 2002-04-11 |
| Date Added to Maude | 2002-07-01 |
| 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 | 21903 ARM SLING W/SWATHE - LARGE |
| Generic Name | BDH BID LINE SHOULDER PRODUCTS |
| Product Code | ILI |
| Date Received | 2002-05-15 |
| Model Number | NA |
| Catalog Number | 21903 |
| 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 | 391213 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | 21903 ARM SLING W/SWATHE-L |
| Baseline Generic Name | ARM SLING |
| Baseline Model No | NA |
| Baseline Catalog No | 21903 |
| Baseline ID | NA |
| Baseline Device Family | SHOULDER PRODUCTS |
| 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 | 2002-05-15 |