MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-08-25 for SHOE COVER, SMS, NONSKID, REG SZ NON28858 * manufactured by Medline Industries, Inc..
[18236921]
A nurse was wearing the shoe covers in the nursery when she reportedly turned away from a bassinette, her foot slid out from under her and she fell and injured her knee. She had an mri and required physical therapy. She was on restricted duty for two months and is now back to work full time.
Patient Sequence No: 1, Text Type: D, B5
[18357928]
The sample is expected to be returned for evaluation. It has not yet been received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2006-00017 |
| MDR Report Key | 775326 |
| Report Source | 05 |
| Date Received | 2006-08-25 |
| Date of Report | 2006-07-24 |
| Date of Event | 2006-06-14 |
| Date Mfgr Received | 2006-07-24 |
| Date Added to Maude | 2006-11-02 |
| 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 | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOE COVER, SMS, NONSKID, REG SZ |
| Generic Name | SHOE COVERS |
| Product Code | FXP |
| Date Received | 2006-08-25 |
| Model Number | NON28858 |
| Catalog Number | * |
| Lot Number | 602610920 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 763106 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | * MUNDELEIN IL * US |
| Baseline Brand Name | SHOE COVER, SMS, NONSKID, REG SZ |
| Baseline Generic Name | SHOE COVERS |
| Baseline Model No | NON28858 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-08-25 |