MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-26 for DEROYAL ABDOMINAL BINDER A131056 manufactured by Deroyal Guatemala.
[5020054]
Pt developed red, raised, itchy rash were abdominal binder was. This facility has experienced multiple similar problems with this device over the last year. The mfr has been contacted and product has been provided to the mfr. Pts with no known allergy to latex are affected. Abdominal support s/p c-section.
Patient Sequence No: 1, Text Type: D, B5
[12414927]
We have contacted the customer to try to see if product samples is still available for eval but it was not. Investigation findings: the complaint sample was not returned, no mfg defect was reported. The bom for the a131056 was printed along with latex, labeling. No recent material changes have been made to the materials, the last document by eco (b)(4) in 2011, attached. Raw material number (b)(4) msds/npe/coc/latex added as well as a131067. Add'l material testing showed no issue with the material to cause irritation. Correction: none required. Root cause analysis: unable to determine, several factors may cause allergic reactions including pts own sensitivity to prescriptions/chemicals/materials/dyes, (other than latex) as well as heat related rashes. Corrective action and/or systematic correction action taken: no action required at this time, no mfg issue was found. Will be working towards notifying the hosp of our findings. No further info is available at this time. Will provide follow ups if info becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005225477-2014-00022 |
| MDR Report Key | 4181040 |
| Report Source | 05 |
| Date Received | 2014-09-26 |
| Date of Report | 2014-09-26 |
| Date of Event | 2014-07-25 |
| Date Facility Aware | 2014-07-25 |
| Report Date | 2014-09-26 |
| Date Reported to FDA | 2014-08-15 |
| Date Mfgr Received | 2014-08-21 |
| Date Added to Maude | 2014-10-21 |
| 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 LN |
| 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 | 2014-09-26 |
| Catalog Number | A131056 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2014-09-26 |