MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-10 for SPECIALIST STERILE CAST PADDING * 9044S manufactured by Bsn Medical.
[16752448]
Sterile cast padding package was unwrapped to apply to the patient's limb after surgery. The employee noticed a wing from a bug on the padding before it was placed on the patient. The employee unwrapped more of the padding and noticed a dead bug. The packaging for this product was intact prior to opening it. New padding obtained. No patient harm. What was the original intended procedure? Wrap a limb after a surgical procedure. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3117418 |
| MDR Report Key | 3117418 |
| Date Received | 2013-05-10 |
| Date of Report | 2013-05-10 |
| Date of Event | 2013-05-01 |
| Report Date | 2013-05-10 |
| Date Reported to FDA | 2013-05-10 |
| Date Reported to Mfgr | 2013-05-17 |
| Date Added to Maude | 2013-05-17 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | SPECIALIST STERILE CAST PADDING |
| Generic Name | BANDAGE, CAST |
| Product Code | ITG |
| Date Received | 2013-05-10 |
| Model Number | * |
| Catalog Number | 9044S |
| Lot Number | 72345-02 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BSN MEDICAL |
| Manufacturer Address | 1011 KEISLER ROAD CONOVER NC 28613 US 28613 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-10 |