MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-04-10 for DISPOSABLE RECEIVING SHEET 30-BY-B manufactured by Global Healthcare.
[2608505]
Global healthcare (ghc) supplies bulk, non-sterile infant receiving blankets to a customer in (b)(6). On (b)(6) 2012, the customer, who is a distributor of medical products advised that an end user (hospital) had found and reported units in certain lots of the product "contaminated with black spots or particles". In a subsequent communication dated (b)(6), the customer advised ghc that the end user had obtained microbiological testing indicating that the blankets were contaminated with e-coli". The product did not come into contact with a pt and there is no report of injury. Upon receipt of the initial notification ghc began an investigation. Requests for samples of the product alleged to be contaminated have been made and the samples received for eval and testing. The investigation remains ongoing at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004635124-2012-00001 |
| MDR Report Key | 2536415 |
| Report Source | 08 |
| Date Received | 2012-04-10 |
| Date of Report | 2012-04-10 |
| Date of Event | 2012-03-01 |
| Date Mfgr Received | 2012-03-12 |
| Date Added to Maude | 2012-09-11 |
| 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 | 11350 OLD ROSWELL RD, STE 700 |
| Manufacturer City | ALPHARETTA GA 10003 |
| Manufacturer Country | US |
| Manufacturer Postal | 10003 |
| Manufacturer Phone | 7705227520 |
| Manufacturer G1 | XIANTAO SHUANGYAN PLASTICS CO., LTD. |
| Manufacturer Street | NO. 77, XIANHONG RD XINLIRENKOU IND 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 | DISPOSABLE RECEIVING SHEET |
| Generic Name | INFANT RECEIVING BLANKET |
| Product Code | KME |
| Date Received | 2012-04-10 |
| Returned To Mfg | 2012-03-29 |
| Model Number | 30-BY-B |
| Lot Number | NONO45,47,51 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLOBAL HEALTHCARE |
| Manufacturer Address | 11350 OLD ROSWELL RD STE 700 ALPHARETTA GA 30009 US 30009 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-10 |