MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-02-13 for EYE PROTECTION GLASSES UNK manufactured by Depuy Orthopaedics, Inc..
[15490189]
An o. R. Employee received a bloodborne pathogen contamination today during a total hip procedure. They were wearing eye protection glasses with the depuy logo and blood spurted over the top of the glasses and down into their eyes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2004-00088 |
| MDR Report Key | 511608 |
| Report Source | 05 |
| Date Received | 2004-02-13 |
| Date of Report | 2004-01-15 |
| Date of Event | 2004-01-15 |
| Date Facility Aware | 2004-01-15 |
| Report Date | 2004-01-15 |
| Date Mfgr Received | 2004-01-15 |
| Date Added to Maude | 2004-02-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HANS KUSSEROW, MGR. |
| Manufacturer Street | 700 ORTHOPAEDIC DR |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727416 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DR |
| Manufacturer City | WARSAW IN 46581098 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0988 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EYE PROTECTION GLASSES |
| Generic Name | O.R. PRODUCT |
| Product Code | HOY |
| Date Received | 2004-02-13 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 500577 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR WARSAW IN 465810988 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-02-13 |