MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-13 for ACROBAT ARM 241047 manufactured by Ondal.
[276674]
Suspension arm supporting liebel-flarsheim high pressure injector broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2082246-2002-00003 |
| MDR Report Key | 402608 |
| Date Received | 2002-04-13 |
| Date of Event | 2001-12-21 |
| Date Reported to FDA | 2002-04-15 |
| Date Reported to Mfgr | 2002-04-12 |
| Date Added to Maude | 2002-07-03 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | ACROBAT ARM |
| Generic Name | SUSPENSION ARM |
| Product Code | IYB |
| Date Received | 2002-04-13 |
| Model Number | 241047 |
| Catalog Number | 241047 |
| Lot Number | NOT KNOWN |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 391617 |
| Manufacturer | ONDAL |
| Manufacturer Address | * HUNFELD GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-04-13 |