MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-03-17 for ORMCO C-TYPE RELEASE MODULES 715-2020 manufactured by Ormco Corp..
[123400]
This report was rec'd via the orthodontist who reported that the c-type release modules would not easily release from the c-clip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-1998-00002 |
| MDR Report Key | 157711 |
| Report Source | 05 |
| Date Received | 1998-03-17 |
| Date of Report | 1998-01-15 |
| Date of Event | 1998-01-01 |
| Date Mfgr Received | 1998-03-10 |
| Device Manufacturer Date | 1997-10-01 |
| Date Added to Maude | 1998-03-20 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORMCO C-TYPE RELEASE MODULES |
| Generic Name | RELEASE MODULES USED WITH ORTHODONTIC HEADGEAR |
| Product Code | DZB |
| Date Received | 1998-03-17 |
| Returned To Mfg | 1998-01-21 |
| Model Number | NA |
| Catalog Number | 715-2020 |
| Lot Number | 7L1 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 153656 |
| Manufacturer | ORMCO CORP. |
| Manufacturer Address | 1332 S. LONE HILL AVE. GLENDORA CA 91740 US |
| Baseline Brand Name | C-TYPE RELEASE MODULES |
| Baseline Generic Name | RELEASE MODULES USED WITH ORTHODONTIC HEADGEAR |
| Baseline Model No | NA |
| Baseline Catalog No | 715-2020 |
| Baseline ID | NA |
| Baseline Device Family | EXTRAORAL ORTHODONTIC HEADGEAR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K902645 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-03-17 |