MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-02 for GAUZE SPONGE CUSTOM OCCULOPLASTY PACK * SEY340PBLW manufactured by Cardinal.
[2865957]
Debris found in 4x4 guaze sponge from cardinal custom occuloplasty pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2697659 |
| MDR Report Key | 2697659 |
| Date Received | 2012-08-02 |
| Date of Report | 2012-08-02 |
| Date of Event | 2012-07-18 |
| Report Date | 2012-08-02 |
| Date Reported to FDA | 2012-08-02 |
| Date Added to Maude | 2012-08-14 |
| 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 | 3 |
| 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 | GAUZE SPONGE CUSTOM OCCULOPLASTY PACK |
| Generic Name | GAUZE SPONGE CUSTOM OCCULOPLASTY PACK |
| Product Code | OJK |
| Date Received | 2012-08-02 |
| Model Number | * |
| Catalog Number | SEY340PBLW |
| Lot Number | 855712 |
| ID Number | * |
| Device Availability | N |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL |
| Manufacturer Address | 1320 DON HASKINS SUITE A EL PASO TX 79936 US 79936 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-02 |