MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2007-08-21 for X-TRA TRACTION* SHOE COVER XLG 69254 manufactured by Kunshan Aieda Non-woven Products Co. Ltd..
[17020078]
A report was received from the user facility that there were several calls regarding falls associated with the use of extratraction shoe covers product. There were no injury or medical intervention. The site expressed concerned of potential liability associated with future incidents. Example given was transport of the transplant patient. Kimberly-clark has no independent knowledge of the event reported above but is relaying the information that was provided by the facility where the incident occurred. This product incident is documented in the kimberly-clark complaint database and identified.
Patient Sequence No: 1, Text Type: D, B5
[17230201]
Four potential lot numbers were cited by the user facility. These lots were manufactured from april 2006 though february 2007. The shoe cover is coated with a hot melt skid resistant coating. The contract manufacturer has performed the following analyses on various complaint samples related to skid-resistant shoe cover performance: coefficient of friction; glue application; and traction loss. The manufacture site has reinforced machine maintenance, on-line operator and quality inspectors follow the correct shoe covers manufacturing operation, and attention to appropriate hot melt shoe coating.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615517-2007-00097 |
| MDR Report Key | 898872 |
| Report Source | 06,07 |
| Date Received | 2007-08-21 |
| Date of Report | 2007-08-21 |
| Date of Event | 2007-07-24 |
| Date Mfgr Received | 2007-07-24 |
| 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 | 0 |
| Manufacturer Contact | SALLY HERRICK |
| Manufacturer Street | 1400 HOLCOMB BRIDGE ROAD |
| Manufacturer City | ROSWELL GA 90076 |
| Manufacturer Country | US |
| Manufacturer Postal | 90076 |
| Manufacturer G1 | KUNSHAN AIEDA NON-WOVEN PROD.CO. LTD. |
| Manufacturer Street | 168 HUAYUAN RD., ZHANGPU TOWN |
| Manufacturer City | KUNSHAN, JIANGSU PROV. 215321 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215321 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X-TRA TRACTION* SHOE COVER XLG |
| Generic Name | SHOE COVER |
| Product Code | FXP |
| Date Received | 2007-08-21 |
| Returned To Mfg | 2007-07-26 |
| Model Number | NA |
| Catalog Number | 69254 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 965381 |
| Manufacturer | KUNSHAN AIEDA NON-WOVEN PRODUCTS CO. LTD. |
| Manufacturer Address | KUNSHAN, JIANGSU PROV. CH 215321 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-21 |