MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-28 for STAPH CHECK II PILLOW * 000SC1 manufactured by Herculite Products, Inc..
[21960807]
Hosp used a pillow, after pillow was sanitized, hosp employee looked inside pillow & found an area that had been contaminated with a bodily fluid & blood. Pillow seemed to be able to let a fluid penetrate to inside contents. Was not known how long pillow had been saturated. A pillow was put in its place. A pillow case was used on this reusable pillow for every use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011965 |
| MDR Report Key | 116095 |
| Date Received | 1997-08-28 |
| Date of Report | 1997-08-26 |
| Date of Event | 1997-08-05 |
| Date Added to Maude | 1997-09-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAPH CHECK II PILLOW |
| Generic Name | PILLOW |
| Product Code | KME |
| Date Received | 1997-08-28 |
| Model Number | * |
| Catalog Number | 000SC1 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 113915 |
| Manufacturer | HERCULITE PRODUCTS, INC. |
| Manufacturer Address | P.O. BOX 786 YORK PA 17405 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-08-28 |