MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-12 for DEROYAL ABDOMINAL BINDER NOT PROVIDED manufactured by Deroyal Guatemala.
[4912314]
Pt s/p c-section developed rash on abdomen two days after abdominal binder was in place. Md was called about rash and abdominal binder will not be reapplied to pt. Staff did not save the packaging so the lot and ref number are unavailable; however, the facility has had multiple similar problems with this device. Pts have developed a similar rash within 24-48 hours of placement of the abdominal binder. Previous product has been returned.
Patient Sequence No: 1, Text Type: D, B5
[12396000]
The complaint was received via fda on (b)(4) 2014. We have contacted the customer to try to see if product samples are still available for eval but they were not. The complaint sample was not returned, no mfg defect was reported. The bom for the (b)(4) was printed along with latex, labeling. No recent material changes have been made to the materials, the last was documented by eco (b)(4) in 2011, attached. Raw material number (b)(4) added as well as (b)(4). Additional material testing has been initiated by ra. Biocompatability 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/chemical/materials/dyes (other than latex) as well as heat related rashes. Corrective 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 | 3005225477-2014-00021 |
| MDR Report Key | 4143621 |
| Report Source | 05 |
| Date Received | 2014-09-12 |
| Date of Report | 2014-09-12 |
| Date of Event | 2014-07-16 |
| Date Facility Aware | 2014-07-06 |
| Report Date | 2014-09-12 |
| Date Reported to FDA | 2014-07-17 |
| Date Mfgr Received | 2014-08-07 |
| Date Added to Maude | 2014-10-09 |
| 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 |
| 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 |
| Product Code | FSD |
| Date Received | 2014-09-12 |
| Catalog Number | NOT PROVIDED |
| 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 CARRATERA A VILLA CANALES VILLA CANALES GT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-12 |