MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-07-22 for 13992000 AB BNDR 9" UNIV 46-62 manufactured by Deroyal Industries, Inc..
[277566]
A pt developed a rash after using an abdominal binder. Pt doesn't know if pt is allergic to latex. Pt has never had a reaction before the binder was given to pt at hospital following hysterectomy surgery. Pt wore it from friday until monday when pt came home. After taking a shower, the rash got worse. The dr has given pt medication for the rash, and pt no longer has to wear the binder. No replacement binder is needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037420-2002-00011 |
| MDR Report Key | 406403 |
| Report Source | 00 |
| Date Received | 2002-07-22 |
| Date of Report | 2002-07-22 |
| Date of Event | 2002-06-21 |
| Report Date | 2002-06-21 |
| Date Mfgr Received | 2002-06-21 |
| Date Added to Maude | 2002-07-25 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 13992000 AB BNDR 9" UNIV 46-62 |
| Generic Name | DBG DEBQL CHEST PRODUCTS |
| Product Code | FSD |
| Date Received | 2002-07-22 |
| Model Number | NA |
| Catalog Number | 13992000 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 395390 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | 13992000 AB BNDR 9" UNIV 46-62 |
| Baseline Generic Name | DBG DEBQL CHEST PRODUCTS |
| Baseline Model No | NA |
| Baseline Catalog No | 13992000 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-07-22 |