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 |