MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-06-04 for SHOE COVER, SMS, NON-SKID, X-L S NON28859 manufactured by Medline Industries, Inc..
[662669]
The facility stated, there were three separate occurrences related to the use of the shoe covers in a one week period. Two of the occurrences occurred in the or and one in the nursery. The covers were alleged to be missing the non-skid strips and three employees fell when walking in them. No serious injury occurred as the result of the falls and no medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
[7967345]
Samples received and sent to mfr for evaluation. A follow up report will be filed once the results are received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2007-00025 |
| MDR Report Key | 863137 |
| Report Source | 06 |
| Date Received | 2007-06-04 |
| Date of Report | 2007-05-31 |
| Date of Event | 2007-05-01 |
| Date Facility Aware | 2007-05-09 |
| Date Added to Maude | 2008-02-28 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOE COVER, SMS, NON-SKID, X-L S |
| Generic Name | SHOE COVER, OPERATING ROOM |
| Product Code | BWP |
| Date Received | 2007-06-04 |
| Returned To Mfg | 2007-05-18 |
| Model Number | NON28859 |
| Lot Number | 4502862803 - 5CS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 957997 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-04 |