MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,06 report with the FDA on 2002-07-05 for 13992000 AB BNDR 9" UNIV 46-62 manufactured by Deroyal Industries, Inc..
[289537]
Redness and itching was reported by a pt after wearing an abdominal binder for one day. The pt had a spinal cord stimulator battery and lead removal surgery in 2002. Pt was instructed to wear the binder over a tee shirt. When the nurse called the pt on follow-up the next day to check on then, the pt reported the redness and itching. The skin is still red today, 06/2002. The customer will check with the hospital's purchasing dept to see if the pt charge sticker listed the lot number. If not, the lot number will not be retrievable. Ups will pick up the binder for return to co.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037420-2002-00009 |
| MDR Report Key | 404159 |
| Report Source | 03,06 |
| Date Received | 2002-07-05 |
| Date of Report | 2002-07-03 |
| Date of Event | 2002-04-29 |
| Date Facility Aware | 2002-04-29 |
| Report Date | 2002-06-04 |
| Date Mfgr Received | 2002-06-04 |
| Date Added to Maude | 2002-07-12 |
| 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 |
| Removal Correction Number | NA |
| 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 | 2002-07-05 |
| Model Number | NA |
| Catalog Number | 13992000 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 393150 |
| 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 | 2002-07-05 |