MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-03-27 for DEROYAL PREMIE ARMBOARD * manufactured by Deroyal Industries.
[134271]
Med record reviewed on 3-16-98. Per report rec'd, several small lacerations noted on infant's left arm, one at inner aspect 1cm above wrist and another 2 cm below antecubital. These lacerations were scabbed over. The location of the lacerations were consistent with the edges of the armboard. Armboard was padded to prevent further injury. No treatment given and left open to air. Next day no redness or drainage noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 159892 |
| MDR Report Key | 159892 |
| Date Received | 1998-03-27 |
| Date of Report | 1998-03-16 |
| Date of Event | 1998-02-19 |
| Date Facility Aware | 1998-02-19 |
| Report Date | 1998-03-16 |
| Date Reported to FDA | 1998-03-17 |
| Date Reported to Mfgr | 1998-03-17 |
| Date Added to Maude | 1998-04-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL PREMIE ARMBOARD |
| Generic Name | ARMBOARD |
| Product Code | BTX |
| Date Received | 1998-03-27 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | M8125P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 155720 |
| Manufacturer | DEROYAL INDUSTRIES |
| Manufacturer Address | 200 DEBUSK LN. POWELL TN 37849 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-03-27 |