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 2004-02-18 for SRI LIQUID PROOF SURGICAL GOWN 7503 manufactured by Sri/surgical Express, Inc..
[354580]
Doctor reported experiencing strike through of fluids inside sleeve (cuff area) of a liquid proof surgical gown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1527607-2004-00001 |
| MDR Report Key | 525784 |
| Report Source | 05,06,07 |
| Date Received | 2004-02-18 |
| Date of Report | 2004-02-05 |
| Date of Event | 2004-01-06 |
| Date Mfgr Received | 2004-01-06 |
| Device Manufacturer Date | 2004-01-01 |
| Date Added to Maude | 2004-05-21 |
| 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 | JOYCE MOODY, DIR |
| Manufacturer Street | 12425 RACE TRACK ROAD |
| Manufacturer City | TAMPA FL 33626 |
| Manufacturer Country | US |
| Manufacturer Postal | 33626 |
| Manufacturer Phone | 8138919550 |
| 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 LIQUID PROOF SURGICAL GOWN |
| Generic Name | LARGE SURGICAL GOWN |
| Product Code | FYB |
| Date Received | 2004-02-18 |
| Model Number | NA |
| Catalog Number | 7503 |
| Lot Number | NOT REPORTED TO SRI |
| ID Number | BARCODE # NOT REPORTED TO SRI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 514922 |
| Manufacturer | SRI/SURGICAL EXPRESS, INC. |
| Manufacturer Address | 7086 INDUSTRIAL ROW RD. MASON OH 45040 US |
| Baseline Brand Name | LARGE LIQUID PROOF GOWN |
| Baseline Generic Name | LIQUID PROOF SURGICAL GOWN |
| Baseline Model No | NA |
| Baseline Catalog No | 7503 |
| Baseline ID | NA |
| Baseline Device Family | LIQUID PROOF SURGICAL GOWN |
| Baseline Shelf Life [Months] | NA |
| 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 | 2004-02-18 |