MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-11-23 for GLOBAL HEALTHCARE MATTRESS SHEET 41-MS2 manufactured by Global Healthcare.
[19205985]
On (b)(6), 2010, (b)(6) was contacted via phone by ms. (b)(6), an employee of hospital (b)(6) advising that on (b)(6), 2010, a (b)(6) female pt was admitted to the emergency room with a high fever and after lying on a mattress covered by a fitted sheet supplied by (b)(6), she developed dermatitis. The symptoms were described as "first and second degree burns". (b)(6) launched an investigation of the incident; however, despite repeated requests to the complainant hospital, (b)(6) has been provided with little further info. On (b)(6), 2010, our distributor in (b)(4) was able to provide us with lot numbers for the products and sample sheets from the lots. This info is being used to investigate the incident with the contract mfr of the product. To date, (b)(6) has received no further info regarding the pt, her identification or any records relating to the diagnosis, treatment or condition of the pt to help ascertain whether the condition may have been caused by the fitted sheet. The investigation remains ongoing at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004635124-2010-00001 |
| MDR Report Key | 1942490 |
| Report Source | 05 |
| Date Received | 2010-11-23 |
| Date of Report | 2010-11-23 |
| Date of Event | 2010-10-02 |
| Date Mfgr Received | 2010-10-05 |
| Date Added to Maude | 2011-01-24 |
| 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 | 1495 HEMBREE RD. SUITE 700 |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer Phone | 7705227520 |
| Manufacturer G1 | XIANTAO SHUANGYAN PLASTIC PRODUCTS CO., LTD. |
| Manufacturer Street | XILIRENKOU INDUST. AREA ZHANGGOU TOWN |
| Manufacturer City | XIANTAO, HUBEI 433012 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 433012 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLOBAL HEALTHCARE MATTRESS SHEET |
| Product Code | KME |
| Date Received | 2010-11-23 |
| Model Number | 41-MS2 |
| Lot Number | PO114-10/PO225-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLOBAL HEALTHCARE |
| Manufacturer Address | 1495 HEMBREE RD. SUITE 700 ROSWELL GA 30076 US 30076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-11-23 |