MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-01-20 for NOVAPLUS EXTRA TRACTION - XL 69195 manufactured by Kimberly-clark Health Care.
[21977395]
The investigation of this event is ongoing, and a supplemental report will be submitted if additional relevant information is identified. Information from this incident will be included in our product complaint and mdr trend reporting systems. Ongoing analysis of trend information is used to identify the need for additional investigations. Information from this event has been captured in complaint # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[21984639]
Kimberly-clark received a report stating, "two separate slip/fall incidents were reported in (b)(6) in the hospital lab and or. According to a report from the distributor (b)(4), one of the employees that fell had to spend a night in the hospital. It was reported that the product being used during the incident did not have adequate tread/grip. " kimberly-clark has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the kimberly-clark complaint database and identified as record #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083545-2012-00001 |
| MDR Report Key | 2424059 |
| Report Source | 07 |
| Date Received | 2012-01-20 |
| Date of Report | 2011-12-23 |
| Date Mfgr Received | 2011-12-23 |
| Date Added to Maude | 2012-01-23 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MR RA/QA AE COORDINATOR |
| Manufacturer Street | 1400 HOLCOMB BRIDGE RD BLDG 200 |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705877200 |
| Manufacturer G1 | A PLUS INTERNATIONAL |
| Manufacturer City | CHINO CA 91710 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91710 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVAPLUS EXTRA TRACTION - XL |
| Generic Name | SHOE COVER |
| Product Code | FXP |
| Date Received | 2012-01-20 |
| Catalog Number | 69195 |
| Lot Number | CA1253003 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK HEALTH CARE |
| Manufacturer Address | 1400 HOLCOMB BRIDGE RD BLDG 200 ROSWELL GA 30076 US 30076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-01-20 |