MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 1997-01-18 for SLOTTED ADULT HEAD POSITIONER 30030 31143160 manufactured by Graphic Controls Corp. (devon Industries).
[42368]
Pt had undergone back surgery and the surgery was of a longer duration (approx. 4-5 hrs) than normal. Pt was in the prone position during this period. Apparently after the surgery, pt experiened some redness and swelling of the face and was also being treated for a problem with his vision. It was reported that pt incurred an injury to his left eye, allegedly from facial contact with the bareskin foam headrest used by the hospital during the surgery to position and cushion the face during surgical procedures. Drops were applied to the left eye after injury. It is unk what other treatment the pt may have received. Current condition and prognosis is unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020423-1997-00001 |
| MDR Report Key | 63882 |
| Report Source | 00,07 |
| Date Received | 1997-01-18 |
| Date of Report | 1996-12-18 |
| Date of Event | 1995-08-15 |
| Date Facility Aware | 1995-08-15 |
| Report Date | 1996-12-18 |
| Date Mfgr Received | 1996-12-18 |
| Date Added to Maude | 1997-01-24 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLOTTED ADULT HEAD POSITIONER |
| Generic Name | PT POSITIONING PRODUCT |
| Product Code | HBM |
| Date Received | 1997-01-18 |
| Model Number | 30030 |
| Catalog Number | 31143160 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 64031 |
| Manufacturer | GRAPHIC CONTROLS CORP. (DEVON INDUSTRIES) |
| Manufacturer Address | 9530 DESOTO AVE CHATSWORTH CA 91311 US |
| Baseline Brand Name | SLOTTED ADULT HEAD POSITIONER |
| Baseline Generic Name | HEAD REST |
| Baseline Model No | 30030 |
| Baseline Catalog No | 31143160 |
| Baseline ID | NA |
| Baseline Device Family | DEVON POSITIONING PLUS SYSTEM |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 1997-01-18 |