MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2014-03-14 for PORTEX TRACHEOSTOMY TUBE STRAP 69-0675TS manufactured by Smiths Medical International Ltd..
[15883659]
Smiths medical has received the sample device. A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site. Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed. Explanation of method code (other): the actual device involved was returned and is currently in transit to the investigation site.
Patient Sequence No: 1, Text Type: N, H10
[15995845]
A report was received from a patient alleging that the listed tracheostomy tube strap separated during use while sleeping. The patient alleged that the tracheostomy tube then shifted to one side so that the airway was temporarily blocked. The patient then awoke, finding that the tube had shifted. The patient reported that he did not seek medical attention, but did endure a headache following the event. No permanent adverse effects to patient were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183502-2014-00115 |
| MDR Report Key | 3690522 |
| Report Source | 04,08 |
| Date Received | 2014-03-14 |
| Date of Report | 2014-03-13 |
| Date of Event | 2014-02-12 |
| Date Facility Aware | 2014-02-12 |
| Report Date | 2014-03-13 |
| Date Reported to FDA | 2014-03-13 |
| Date Mfgr Received | 2014-02-12 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-03-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PETE HIRTE |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287384 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | BOUNDRY ROAD |
| Manufacturer City | HYTHE, KENT CT216JL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CT21 6JL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX TRACHEOSTOMY TUBE STRAP |
| Generic Name | JAY - SUPPORT, BREATHING TUBE |
| Product Code | JAY |
| Date Received | 2014-03-14 |
| Returned To Mfg | 2014-02-25 |
| Model Number | NA |
| Catalog Number | 69-0675TS |
| Lot Number | 1327033 |
| ID Number | NA |
| Device Expiration Date | 2018-08-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Address | HYTHE, KENT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-03-14 |