MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-12-18 for 5151-01 ABD BNDR 30-45" 5115-01 manufactured by Deroyal.
[201082]
After approx wearing the abdominal binder a little over a week, the pt had to take the product off due to rash. Rash continued to get worse for approx a week after the pt removed the product. The pt had begun wearing the product after hernia surgery. The pt returned to the dr who gave a cream for the rash. The rash completely covered where the binder touched and itched really bad. The pt has returned the product to the co.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037420-2000-00005 |
| MDR Report Key | 309968 |
| Report Source | 00 |
| Date Received | 2000-12-18 |
| Date of Report | 2000-12-15 |
| Date of Event | 2000-11-14 |
| Date Mfgr Received | 2000-11-15 |
| Date Added to Maude | 2000-12-29 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5151-01 ABD BNDR 30-45" |
| Generic Name | SIZED ABDOMINAL BINDER |
| Product Code | FSD |
| Date Received | 2000-12-18 |
| Returned To Mfg | 2000-12-13 |
| Model Number | NA |
| Catalog Number | 5115-01 |
| Lot Number | NOT GIVEN |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 299886 |
| Manufacturer | DEROYAL |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | DEROYAL |
| Baseline Generic Name | BINDER, ABDOMINAL |
| Baseline Model No | NA |
| Baseline Catalog No | 5115-01 |
| Baseline ID | NA |
| Baseline Device Family | ABDOMINAL BINDER |
| 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; 2. Required No Informationntervention | 2000-12-18 |