MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-03-23 for @SHOE COVER, SMS, NON-SKIN,X-L S NON28859 manufactured by Medline Industries, Inc..
[1062896]
It was reported that an employee went to sit on a stool and as it began to roll away, she slipped and fell, injuring her back.
Patient Sequence No: 1, Text Type: D, B5
[8180407]
It was reported that a staff member fell while wearing the non-skid shoe covers. There was no water on the floor. She apparently went to sit down on a stool and the stool began rolling. She tried to brace herself and her feet slid. She fell and suffered a contusion to her back. She was evaluated in the emergency room. She is receiving physical therapy. No sample was provided for eval. Samples from stock as well as samples from other vendors have been sent to a testing house to have the slip measured per astm f 1677. At this time, no root cause has been identified and no corrective action is indicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2009-00022 |
| MDR Report Key | 1351562 |
| Report Source | 05,06 |
| Date Received | 2009-03-23 |
| Date of Report | 2009-03-17 |
| Date of Event | 2009-02-18 |
| Date Facility Aware | 2009-02-19 |
| Date Added to Maude | 2009-10-30 |
| 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 | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PL. |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PL. |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | @SHOE COVER, SMS, NON-SKIN,X-L S |
| Generic Name | NONE |
| Product Code | BWP |
| Date Received | 2009-03-23 |
| Model Number | NON28859 |
| Lot Number | 84105972-2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-23 |