MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-01-03 for MEROCEL 2000, 8CM WITH AIRWAY AND DRAWSTRING 10XBOX, STERILE 470405 manufactured by Medtronic Ent.
[774179]
The doctor reported that the patient had septal reconstruction surgery with inferior turbinate reductions at the same time. A solution (bacitracin) was applied to the doyle airway splints, and they were placed in the usual fashion on both sides of the nose. No trimming was done to the splints before placement, and the drawstrings were not used. The patient said that three days later, one of the doyle splints was aspirated down his throat. It caused severe choking and consternation to the point where he almost suffocated.
Patient Sequence No: 1, Text Type: D, B5
[8093690]
The drawstring intended to prevent aspiration of the splint was not used. User failed to follow the instructions (ifu) that were provided, which is to tape the drawstring/locator string to the patient's face. It is a single-use device that contains one splint and one ifu per package, ten packages per box. The doctor requested information re: how to file adverse event reports with fda and we provided him this information. It is not known if his medwatch report was filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2008-00001 |
| MDR Report Key | 973058 |
| Report Source | 05 |
| Date Received | 2008-01-03 |
| Date of Report | 2008-01-03 |
| Date of Event | 2007-11-23 |
| Date Mfgr Received | 2007-12-04 |
| Device Manufacturer Date | 2006-06-20 |
| Date Added to Maude | 2008-01-08 |
| 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 Contact | DAVE TIMLIN, DIRECTOR |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9072797532 |
| Manufacturer G1 | MEDTRONIC ENT |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEROCEL 2000, 8CM WITH AIRWAY AND DRAWSTRING 10XBOX, STERILE |
| Generic Name | MEROCEL STERILE DISPOSABLE |
| Product Code | EMX |
| Date Received | 2008-01-03 |
| Model Number | 470405 |
| Catalog Number | 470405 |
| Lot Number | 45120400 |
| Device Expiration Date | 2009-06-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 942983 |
| Manufacturer | MEDTRONIC ENT |
| Manufacturer Address | JACKSONVILLE FL 32216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2008-01-03 |