MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2014-10-07 for XTRA TRAC SHOEC, XLG 69254 991069254 manufactured by Kimberly-clark Health Care.
[21729737]
Kimberly-clark received a report stating that the operating room technician slipped and broke her arm while wearing the shoe covers. Additional information received on (b)(4) 2014 states the operating room technician initially changed the shoe covers after a previous endoscopy procedure. The operating room technician was then setting-up the surgical suite for the next procedure, a knee arthroscopy surgery. The operating room technician states after she changed the shoe covers, she went into the break room and then went into the procedure room to set-up for the next case. The floor of procedure room floor was not wet but the operating room technician is unsure if the floor was wet during her walk to and from the break room. The operating room technician walked into the hallway to gather more items for the procedure case and then walked back into procedure room. When she returned to the procedure room, she slipped, fell, and broke her right arm. The operating room technician estimates she wore the shoe covers approximately five minutes prior to the fall. Treatment included wearing an arm cast for 5 weeks, and no additional follow-up treatments were required following removal of the cast.
Patient Sequence No: 1, Text Type: D, B5
[22222840]
(b)(4). The actual complaint product was not returned for evaluation. A review of the device history record is in-progress. Upon completion of the investigation; a follow-up report will be filed. 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 (b)(4). Device not returned by customer.
Patient Sequence No: 1, Text Type: N, H10
[23468461]
The actual complaint product was not returned for evaluation. A review of the device history record is completed. The device history records (dhr) review for the lot number reported indicates that the device was manufactured according to manufacturing requirements. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1033422-2014-00027 |
| MDR Report Key | 4150505 |
| Report Source | 05,06,08 |
| Date Received | 2014-10-07 |
| Date of Report | 2014-09-08 |
| Date of Event | 2014-06-25 |
| Date Mfgr Received | 2014-10-12 |
| Date Added to Maude | 2014-10-08 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LISA CLARK |
| Manufacturer Street | 1400 HOLCOMB BRIDGE ROAD |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer G1 | LIANYUNGANG AIYEH NON-WOVEN PRODUCTS CO., LTD |
| Manufacturer Street | NO. 9 YUNYANG RD. HUANGJIUNIAN EXPORT PROCESSING ZONE |
| Manufacturer City | LIANYUNGANG JIANGSU 2220 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 2220 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XTRA TRAC SHOEC, XLG |
| Generic Name | SURGICAL APPAREL SHOE COVER |
| Product Code | FXP |
| Date Received | 2014-10-07 |
| Model Number | 69254 |
| Catalog Number | 991069254 |
| Lot Number | CA4128001 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK HEALTH CARE |
| Manufacturer Address | 1400 HOLCOMB BRIDGE ROAD ROSWELL GA 30076 US 30076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-07 |