MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-10-30 for SHOE COVER, SPP, NON-SKID, RG SIZE CRI2002 * manufactured by Medline Industries, Inc..
[20196215]
Report received of four falls that occurred while the shoe covers were being worn. This occurred on the unit where they wear shoe covers while in the patient rooms. The shoe cover is reportedly "more slippery than usual. " one employee that fell is pregnant. She twisted her ankle and aggravated back pain associated with her pregnancy. She was off work for a short time and then was placed on light duty work for a couple of weeks. She did not experience any adverse sequelae. One other employee fell twice and bruised her knees. She did not require any medical intervention. The fourth fall was the father of a patient. He reported that he did not get hurt. No further information was available.
Patient Sequence No: 1, Text Type: D, B5
[20447023]
Sample shoe covers were received from the customer. The investigation is on-going. Once the investigation is complete the information will be submitted in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2006-00027 |
| MDR Report Key | 778529 |
| Report Source | 05 |
| Date Received | 2006-10-30 |
| Date of Report | 2006-10-03 |
| Date Mfgr Received | 2006-10-03 |
| Date Added to Maude | 2006-11-09 |
| 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, SPP, NON-SKID, RG SIZE |
| Generic Name | SHOE COVER |
| Product Code | FXP |
| Date Received | 2006-10-30 |
| Returned To Mfg | 2006-10-11 |
| Model Number | CRI2002 |
| Catalog Number | * |
| Lot Number | 602778919 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 766304 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | * MUNDELEIN IL * US |
| Baseline Brand Name | SHOE COVER, SPP, NON-SKID, RG SIZE |
| Baseline Generic Name | SHOE COVER |
| Baseline Model No | CRI2002 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-30 |