MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-05 for PRONE POSITIONER P-39-01 NA manufactured by Voss Medical Products.
[196763]
Pt reported had a 5 to 6 hour back surgery during which the pt was in a prone position. After surgery, pt had a pressure sore on chin that scarred on healing. Scarring was going to require some plastic surgery to reduce or eliminate. It appears pt had been left in contact with the support positioner too long without confirming and or reestablishing blood flow to the pressure points as stated in the product instructions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643116-2001-00001 |
| MDR Report Key | 326013 |
| Date Received | 2001-04-05 |
| Date of Report | 1998-01-05 |
| Date of Event | 1997-04-04 |
| Date Mfgr Received | 1998-01-05 |
| Date Added to Maude | 2001-04-12 |
| 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 | 0 |
| 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 | 2001-04-05 |
| Model Number | P-39-01 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 315466 |
| 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. Required No Informationntervention | 2001-04-05 |