MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-03-11 for SHOE COVER, NON SKID, X-L SZ BL NON28759 manufactured by Medline Industries, Inc..
[1076699]
It was reported that a staff member slipped while wearing the shoe cover. She fell and dislocated her shoulder.
Patient Sequence No: 1, Text Type: D, B5
[8252377]
It was reported that a staff member fell while wearing the show covers and separated her shoulder. She is out on medical leave. The shoe cover involved in the alleged incident was not returned for evaluation. Instead, two unused shoe covers were returned. The shoe covers were not from the reported lot number but rather from two different lot numbers. We are unable to confirm the issue with the info and samples provided. Based on the injury that resulted from this incident, an mdr is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2009-00017 |
| MDR Report Key | 1343235 |
| Report Source | 05,06 |
| Date Received | 2009-03-11 |
| Date of Report | 2009-03-09 |
| Date of Event | 2009-02-12 |
| Date Facility Aware | 2009-02-12 |
| Date Added to Maude | 2009-03-18 |
| 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 | 0 |
| 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, NON SKID, X-L SZ BL |
| Generic Name | NONE |
| Product Code | FXP |
| Date Received | 2009-03-11 |
| Model Number | NON28759 |
| Lot Number | 08064942 |
| 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. Required No Informationntervention | 2009-03-11 |