MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-05-02 for 13652067 12" 4-PANEL AB BINDER 46-62 manufactured by Deroyal Industries, Inc.
[14868465]
Patient developed skin irritation while wearing an abdominal binder. Binder from the incident lot number 865660 was returned for eval in 03/2002.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1125634-2002-00006 |
| MDR Report Key | 392180 |
| Report Source | 06 |
| Date Received | 2002-05-02 |
| Date of Report | 2002-04-26 |
| Report Date | 2002-03-28 |
| Date Mfgr Received | 2002-03-28 |
| Date Added to Maude | 2002-05-08 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 13652067 12" 4-PANEL AB BINDER 46-62 |
| Generic Name | TLG TOP-OF-THE-LINE CHEST PRODUCTS |
| Product Code | FSD |
| Date Received | 2002-05-02 |
| Model Number | NA |
| Catalog Number | 13652067 |
| Lot Number | 865660 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 381209 |
| Manufacturer | DEROYAL INDUSTRIES, INC |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | DEROYAL |
| Baseline Generic Name | ABDOMINAL BINDER |
| Baseline Model No | NA |
| Baseline Catalog No | 13652067 |
| Baseline ID | NA |
| Baseline Device Family | TLG TOP OF THE LINE CHEST PRODUCTS |
| Baseline Shelf Life Contained | N |
| 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 | 2002-05-02 |