MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-10-30 for manufactured by .
| Report Number | 2431497-2002-00001 |
| MDR Report Key | 426793 |
| Report Source | 06 |
| Date Received | 2002-10-30 |
| Date of Event | 2002-10-11 |
| Date Mfgr Received | 2002-10-29 |
| Date Added to Maude | 2002-11-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARTIN PRENSKE |
| Manufacturer Street | 29 WELLS AVE |
| Manufacturer City | YONKERS NY 10701 |
| Manufacturer Country | US |
| Manufacturer Postal | 10701 |
| Manufacturer Phone | 9149632040 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | IQB |
| Date Received | 2002-10-30 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 414758 |
| Baseline Brand Name | SKILL-CARE CORP. |
| Baseline Generic Name | SOFT-BELT-SELF SIDE RELEASE BUCKLE |
| Baseline Model No | 00671509103907 |
| Baseline Catalog No | 301270 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-10-30 |