MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-05-09 for POSEY PHOTOTHERAPY EYE PROTECTORS * 4646 manufactured by J.t. Posey Company.
[17024817]
Family member placed eye shields on pt and made the straps too tight. The family members had not been adequately trained. Pt was placed back under the ultraviolet light. Family members fell asleep. The eye shields slid down over pt's mouth and nose. When nurse entered pt's room, she found the pt arching back and retracting during respirations. After removing the eye shields, the pt had o2 sats of 98%. The patient did not suffer any damage to the eyes due to them being uncovered during treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 544935 |
| MDR Report Key | 544935 |
| Date Received | 2003-05-09 |
| Date of Report | 2003-05-09 |
| Date of Event | 2003-05-03 |
| Report Date | 2003-05-09 |
| Date Reported to FDA | 2003-05-09 |
| Date Added to Maude | 2004-09-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POSEY PHOTOTHERAPY EYE PROTECTORS |
| Generic Name | EYE PROTECTOR |
| Product Code | FOK |
| Date Received | 2003-05-09 |
| Model Number | * |
| Catalog Number | 4646 |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 534343 |
| Manufacturer | J.T. POSEY COMPANY |
| Manufacturer Address | 5635 PECK ROAD ARCADIA CA 910060020 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-05-09 |