MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-30 for PRONE POSITIONER P-39-01 NA manufactured by Voss Medical Products.
[382340]
The pt was in a prone position for an extended period of time during a surgical procedure. Pt developed an abrasion/contusion on the chin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643116-2004-00001 |
| MDR Report Key | 609992 |
| Date Received | 2004-06-30 |
| Date of Report | 2004-06-24 |
| Date of Event | 2000-05-27 |
| Date Mfgr Received | 2004-06-21 |
| Date Added to Maude | 2005-06-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEVE HOLLOWAY |
| Manufacturer Street | 4227 CENTERGATE |
| Manufacturer City | SAN ANTONIO TX 78217 |
| Manufacturer Country | US |
| Manufacturer Postal | 78217 |
| Manufacturer Phone | 2106503124 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRONE POSITIONER |
| Generic Name | HEAD SUPPORT FOR PRONE SURGICAL PROCEDURES |
| Product Code | KIL |
| Date Received | 2004-06-30 |
| Model Number | P-39-01 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 599800 |
| Manufacturer | VOSS MEDICAL PRODUCTS |
| Manufacturer Address | 4227 CENTERGATE SAN ANTONIO TX 78217 US |
| Baseline Brand Name | PRONE POSITIONER |
| Baseline Generic Name | HEAD SUPPORT FOR PHONE POSITION SURGERY |
| Baseline Model No | P-39-01 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K932187 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-06-30 |