MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2005-01-06 for SRI/SURGICAL EXPRESS, INC 7503X manufactured by Sri/surgical Express, Inc..
[313991]
An sdp technician who was washing instruments in a basin of cleaning solution, reported experiencing a strike through of fluid inside the sleeves of a liquidproof surgical gown. It is alleged that the cleaning solution soaked through.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028626-2005-00001 |
| MDR Report Key | 565625 |
| Report Source | 05,06,07 |
| Date Received | 2005-01-06 |
| Date of Report | 2005-01-04 |
| Date of Event | 2004-12-08 |
| Date Mfgr Received | 2004-12-08 |
| Date Added to Maude | 2005-01-18 |
| 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 | 0 |
| Manufacturer Contact | MS. JOYCE MOODY |
| Manufacturer Street | 12425 RACE TRACK ROAD |
| Manufacturer City | TAMPA FL 33626 |
| Manufacturer Country | US |
| Manufacturer Postal | 33626 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SRI/SURGICAL EXPRESS, INC |
| Generic Name | SURGICAL GOWN, LARGE, LIQUIDPROOF, NS |
| Product Code | FYB |
| Date Received | 2005-01-06 |
| Model Number | NA |
| Catalog Number | 7503X |
| Lot Number | 409790 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 555414 |
| Manufacturer | SRI/SURGICAL EXPRESS, INC. |
| Manufacturer Address | * LONG BEACH CA * US |
| Baseline Brand Name | SRI/SURGICAL EXPRESS |
| Baseline Generic Name | LIQUIDPROOF SURGICAL TOWN |
| Baseline Model No | NA |
| Baseline Catalog No | 7503X |
| Baseline ID | NA |
| Baseline Device Family | LIQUIDPROOF SURGICAL GOWN, NS |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K920404 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-01-06 |