MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2002-08-02 for INTRASITE GEL 66027308 manufactured by Smith & Nephew, Inc..
[16267527]
Patient was given intrasite as part of treatment to help keep wound moist and to slightly debride. Patient possibly used the product incorrectly by using longer than suggested, thus, causing a severe infection and the need for hospitalization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017593-2002-00004 |
| MDR Report Key | 408606 |
| Report Source | 07 |
| Date Received | 2002-08-02 |
| Date of Report | 2002-07-23 |
| Date of Event | 2002-07-09 |
| Date Mfgr Received | 2002-07-09 |
| Date Added to Maude | 2002-08-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM IRVIN, VP |
| Manufacturer Street | 11775 STARKEY ROAD PO BOX 4727 |
| Manufacturer City | LARGO FL 337734727 |
| Manufacturer Country | US |
| Manufacturer Postal | 337734727 |
| Manufacturer Phone | 7273921261 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRASITE GEL |
| Generic Name | GRESSINGS, WOUND, AND BURN, HYDROGEL |
| Product Code | MGQ |
| Date Received | 2002-08-02 |
| Model Number | NA |
| Catalog Number | 66027308 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 397598 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 11775 STARKEY RD. LARGO FL 337734727 US |
| Baseline Brand Name | INTRASITE GEL |
| Baseline Generic Name | DRESSINGS, WOUND, AND BURN, HYDROGEL |
| Baseline Model No | NA |
| Baseline Catalog No | 66027308 |
| Baseline ID | NA |
| Baseline Device Family | DRESSINGS, WOUND, AND BURN, HYDROGEL |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K926508 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2002-08-02 |