MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2005-08-05 for AMERINET SHOE COVER W/EXTRA TRACTION, XL 69161 manufactured by Kimberly-clark Corp..
[426374]
"the shoe cover was determined a cause in a fall that happened 2 month ago". (the event date provided is an estimated data based on 60 days prior to the mdr report date). A hosp safety committee's investigation found that the nurse sustained a facial injury after hitting their head in the fall and required stitches. They are in the fall and required stitches. They are back at work now. The hosp did not have the lot number not the date of the fall. Kimberly-clark corporation has no first hand knowledge of the allegations, but is relaying information received from outside sources pursuant to federal regulations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1033422-2005-00049 |
| MDR Report Key | 624493 |
| Report Source | 06 |
| Date Received | 2005-08-05 |
| Date of Report | 2005-08-05 |
| Date of Event | 2005-06-05 |
| Date Mfgr Received | 2005-07-11 |
| Date Added to Maude | 2005-08-08 |
| 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 | LARRY KLUDT |
| Manufacturer Street | 1400 HOLCOMB BRIDGE RD. |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705878279 |
| Manufacturer G1 | UNK |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMERINET SHOE COVER W/EXTRA TRACTION, XL |
| Generic Name | SHOE COVER |
| Product Code | BWP |
| Date Received | 2005-08-05 |
| Model Number | NA |
| Catalog Number | 69161 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 614121 |
| Manufacturer | KIMBERLY-CLARK CORP. |
| Manufacturer Address | 1400 HOLCOMB BRIDGE RD. ROSWELL GA 30076 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-08-05 |