MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-04-25 for X-TRA TRACTION SHOE COVER 69252 manufactured by A Plus International.
[834656]
It has been reported to the mfr by the customer that personnel fell while wearing the shoe cover. He went to employee health because his ankle felt "funny" but he was able to walk unassisted. Customer reported that there is less grip on the shoe covers than before. Customer is out on worker's compensation since 2008, but there has been no further reports of serious injury or death as a result of this product. Kimberly-clark has no independent knowledge of the event reported but is relaying the info that was provided by the user 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
[8059439]
The incident device has not been returned for evaluation. To date, a root cause has not been identified. Investigation process is on-going. A follow-up report will be provided if add'l info becomes available. Info from this incident will be included in our product complaint and mdr trend reporting systems. Ongoing analysis of trend info is used to identify the need for add'l investigations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2083545-2008-00001 |
| MDR Report Key | 1034973 |
| Report Source | 05,06 |
| Date Received | 2008-04-25 |
| Date of Report | 2008-04-25 |
| Date of Event | 2008-03-27 |
| Date Mfgr Received | 2008-03-27 |
| Date Added to Maude | 2009-05-14 |
| 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 Street | 1400 HOLCOMB BRIDGE ROAD B200 |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705877200 |
| Manufacturer G1 | A PLUS INTERNATIONAL, INC. |
| Manufacturer Street | 5138 EUCALYPTUS AVE. |
| Manufacturer City | CHINO CA 91710 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91710 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | X-TRA TRACTION SHOE COVER |
| Generic Name | SHOE COVER |
| Product Code | FXP |
| Date Received | 2008-04-25 |
| Catalog Number | 69252 |
| Lot Number | CA7132005 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A PLUS INTERNATIONAL |
| Manufacturer Address | CHINO CA 91710 US 91710 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-04-25 |