MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-07-27 for * BC31 TB2 manufactured by Pisces Productions Inc.
[362925]
Patient sitting at edge of portable recliner bed in mobile blood bank facility. Bed did not hold and collapsed. The safety pin did not hold.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 545045 |
MDR Report Key | 545045 |
Date Received | 2004-07-27 |
Date of Report | 2004-07-27 |
Date of Event | 2004-06-08 |
Report Date | 2004-07-27 |
Date Reported to FDA | 2004-07-27 |
Date Added to Maude | 2004-09-23 |
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 | * |
Generic Name | PORTABLE RECLINER BED |
Product Code | FML |
Date Received | 2004-07-27 |
Model Number | BC31 TB2 |
Catalog Number | * |
Lot Number | * |
ID Number | * |
Device Availability | Y |
Device Age | 1.5 YR |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 534453 |
Manufacturer | PISCES PRODUCTIONS INC |
Manufacturer Address | 380 A MORRIS ST. SEBASTOPOL CA 95427 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2004-07-27 |