MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-03-30 for 28305 ABDOMINAL BINDER 9" 85-94 02 manufactured by Deroyal Industries, Inc..
[193014]
Customer claims that a deroyal abdominal binder could be related to a pt's outbreak of dermatitis that included a rash, blisters, and an infection that required medical treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037420-2000-00004 |
| MDR Report Key | 272484 |
| Report Source | 06 |
| Date Received | 2000-03-30 |
| Date of Report | 2000-02-29 |
| Date of Event | 2000-02-29 |
| Date Facility Aware | 2000-02-29 |
| Report Date | 2000-02-29 |
| Date Reported to FDA | 2000-03-29 |
| Date Mfgr Received | 2000-02-29 |
| Date Added to Maude | 2000-04-10 |
| 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 LN |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387838 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 28305 ABDOMINAL BINDER 9" 85-94 |
| Generic Name | BDG BID LINE CHEST PRODUCTS |
| Product Code | FSD |
| Date Received | 2000-03-30 |
| Model Number | 02 |
| Catalog Number | 28305 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 263785 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LN POWELL TN 37849 US |
| Baseline Brand Name | 28305 ABDOMINAL BINDER 9" 85-94 |
| Baseline Generic Name | BDG BID LINE CHEST PRODUCTS |
| Baseline Model No | 02 |
| Baseline Catalog No | 28305 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-03-30 |