MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-05-12 for TRACH CARE TRAY STANDARD * 47800 manufactured by Kenmex.
[15678265]
End of twill tape unraveled and worked its way in between the outer and inner two cannulae and into the trachea. Pt has muscular dystrophy and has had tracheostomy for 30+ years. Had changed twill previous tuesday or wednesday (as usually does approx twice a week). Had developed a cold and also noticed a scratching sensation in the back of their throat that pt had attributed to their cold. Pt does inner cannula care about 6 times a day when pt has increased secretions, and pt did last week. When pt went to do trach site care and replace the twill pt realized that about 6-7 inches of thread from the twill had become unraveled and had caught between inner and outer cannula, and had thus been threaded down into their trachea. As soon as pt removed the twill the scratching sensation disappeared and their secretions diminished. Customer states that the quality of the twill has been deteriorating for many years, and that pt has reported this incident to the fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612030-2004-00001 |
| MDR Report Key | 507668 |
| Report Source | 04 |
| Date Received | 2004-05-12 |
| Date of Report | 2003-12-22 |
| Date of Event | 2003-12-21 |
| Date Facility Aware | 2003-12-22 |
| Report Date | 2004-01-21 |
| Date Mfgr Received | 2003-12-22 |
| Date Added to Maude | 2004-01-26 |
| 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 | MARTHA PORTNOW RN |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618547 |
| Manufacturer G1 | KENMEX |
| Manufacturer Street | 9255 CUSTOMHOUSE PLAZA STE A |
| Manufacturer City | SAN DIEGO CA 92173 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRACH CARE TRAY STANDARD |
| Generic Name | TRACH TWILL TAPE |
| Product Code | LRQ |
| Date Received | 2004-05-12 |
| Model Number | * |
| Catalog Number | 47800 |
| Lot Number | 315483464 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 496615 |
| Manufacturer | KENMEX |
| Manufacturer Address | 9255 CUSTOMHOUSE PLAZA SUITE A SAN DIEGO CA 92173 US |
| Baseline Brand Name | TRACHEOSTOMY CARE TRAY |
| Baseline Generic Name | TRACH CARE TRAY |
| Baseline Model No | NA |
| Baseline Catalog No | 47800 |
| Baseline ID | NA |
| Baseline Device Family | TRACH CARE KIT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K761190 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-05-12 |