MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-20 for DEROYAL ABDOMINAL BINDER A131056 manufactured by Deroyal Guatemala.
[19296174]
It was reported that the patient had a rash.
Patient Sequence No: 1, Text Type: D, B5
[19391239]
Investigation findings: the complaint sample was not returned. The bom for the a131067 was printed along with latex, labeling, npe, msds and coc due to a similar complaint (b)(4). No manufacturing issue was found. No recent material changes have been made to the materials. Raw material number 8-4001 msds/npe/coc/latex added as well as (b)(4) (same raw materials just a different length to the (b)(4)) reports/labeling and the bom are attached (from qfi 27680 also reported by this customer) the complaint samples were returned, all products are stained with a foreign substance. Correction: none required. Root cause analysis: unable to determine, several factors may cause allergic reactions including patients own sensitivity to prescriptions/chemicals/materials/dyes, (other than latex) as well as heat related rashes. The complaint samples were returned, all products are stained with a foreign substance; this substance can also be rash related. It also may not be compatible with the chemicals/materials/dyes in the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005225477-2014-00010 |
| MDR Report Key | 3899034 |
| Report Source | 05 |
| Date Received | 2014-05-20 |
| Date of Report | 2014-05-19 |
| Date of Event | 2014-04-23 |
| Date Facility Aware | 2014-04-23 |
| Report Date | 2014-05-19 |
| Date Mfgr Received | 2014-04-23 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2014-07-10 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 8653622333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL ABDOMINAL BINDER |
| Generic Name | BINDER, ABDOMINAL |
| Product Code | FSD |
| Date Received | 2014-05-20 |
| Catalog Number | A131056 |
| Lot Number | 33405645 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL GUATEMALA |
| Manufacturer Address | KM 20.5 CARRETERA A VILLA CANALES VILLA CANALES GT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-20 |