MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-06-03 for NONE manufactured by Typenex Medical Llc.
[3540633]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10748706]
Review of the batch records was performed by wausau coated products, manufacturer of the laminated material used to make the bands. The particular property in question was found to be within specification for the batches. Letter from wausau coated products is attached. Further dialog with the customer indicates that the issue with the device was noted only in the maternity unit of the hospital. No other units that used the device from the same lot reported any defective devices. The maternity unit has since used the product without further issues recorded, making it difficult to isolate the root cause.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005720829-2013-00001 |
| MDR Report Key | 3174324 |
| Report Source | 00 |
| Date Received | 2013-06-03 |
| Date Mfgr Received | 2013-04-26 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2013-06-21 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VARSHA KALYANKAR |
| Manufacturer Street | 303 E WHACKER DRIVE SUITE 1200 |
| Manufacturer City | CHICAGO IL 60601 |
| Manufacturer Country | US |
| Manufacturer Postal | 60601 |
| Manufacturer Phone | 3122977092 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | KSS |
| Date Received | 2013-06-03 |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TYPENEX MEDICAL LLC |
| Manufacturer Address | 303 E WACKER DRIVE STE 311 CHICAGO IL 60601000 US 60601 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-03 |