MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-01-10 for REFILL NTI KIT 7600 manufactured by Heraeus Kulzer, Inc..
[15743529]
A pt, woke at 2:30 a. M. (12-15-99) to take an aspirin. Pt. Took the appliance out to take the aspirin and then placed the nti back in mouth. Feeling that the aspirin had not gone all the way down, the pt. Took another drink of water and that is when the pt swallowed the nti. Pt immediately called the dr. And he told pt. To go to the e. R. Pt. Went and had the appliance scoped out, since an x-ray does not show the appliance. Dr. Has not yet seen the pt and is not sure of the whole story. Dr. Is extremely happy with the nti system and has made several, but now is very concerned about making any more. Follow-up call: pt was fitted with the device about 2 months ago per dr. Pt had it made and it was too tight, then came back in the office and the dr. Adjusted. Then it got too loose and the dr. Adjusted a 2nd time and made it tighter. The last the dr. Heard was that the pt was complaining that the appliance was too loose. Dr. Told the pt not to wear it until the pt came back in to have it tightened. Pt never came back in to have the appliance tightened. Dr said the pt did in fact swallow the nti and it was found below the wind pipe. Pt woke up and could not find the appliance and had a pain in chest. That is when pt called the dr. And doctor recommended going to the e. R.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1925223-2000-00001 |
| MDR Report Key | 258432 |
| Report Source | 05 |
| Date Received | 2000-01-10 |
| Date of Report | 2000-01-01 |
| Date of Event | 1999-12-15 |
| Date Mfgr Received | 1999-12-15 |
| Date Added to Maude | 2000-01-14 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 4315 S. LAFAYETTE BLVD |
| Manufacturer City | SOUTH BEND IN 46614 |
| Manufacturer Country | US |
| Manufacturer Postal | 46614 |
| Manufacturer Phone | 2192910661 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REFILL NTI KIT |
| Generic Name | * |
| Product Code | LQZ |
| Date Received | 2000-01-10 |
| Model Number | 7600 |
| Catalog Number | 7600 |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 250259 |
| Manufacturer | HERAEUS KULZER, INC. |
| Manufacturer Address | 4315 SOUTH LAFAYETTE BLVD. SOUTH BEND IN 46614 US |
| Baseline Brand Name | REFILL NTI KIT |
| Baseline Generic Name | * |
| Baseline Model No | 7600 |
| Baseline Catalog No | 7600 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2000-01-10 |