MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2001-01-24 for MED-TEC UNI-FRAME MT-APU-14 manufactured by Med-tec,inc..
[138204]
The pt was treated with shell last december and claimed allergy to device. Rash appeared between lip and jaw originally and then appeared on whole body. Med-tec's uni-frame shell was used and the pt had a similar reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932738-2001-00001 |
| MDR Report Key | 313833 |
| Report Source | 01 |
| Date Received | 2001-01-24 |
| Date of Report | 2001-01-23 |
| Date of Event | 2001-01-14 |
| Date Mfgr Received | 2001-01-14 |
| Date Added to Maude | 2001-01-30 |
| 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 |
| Manufacturer Contact | DONALD RIIBE |
| Manufacturer Street | P.O. BOX 320 1401 8TH ST S.E. |
| Manufacturer City | ORANGE CITY IA 510410320 |
| Manufacturer Country | US |
| Manufacturer Postal | 510410320 |
| Manufacturer Phone | 7127378688 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MED-TEC UNI-FRAME |
| Generic Name | RADIOGRAPHIC HEAD HOLDER |
| Product Code | IWY |
| Date Received | 2001-01-24 |
| Model Number | MT-APU-14 |
| Catalog Number | MT-APU-14 |
| Lot Number | 19082 |
| ID Number | 90 IWY 21CFR892.1920 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 303514 |
| Manufacturer | MED-TEC,INC. |
| Manufacturer Address | 1401 8TH STREET S.E. ORANGE CITY IA 51041 US |
| Baseline Brand Name | MED-TEC UNI-FRAME |
| Baseline Generic Name | RADIOGRAPHIC HEAD HOLDER |
| Baseline Model No | MT-APU-14 |
| Baseline Catalog No | MT-APU-14 |
| Baseline ID | HEAD IMMOBILIZA |
| Baseline Device Family | PATIENT POSITIONING & IMMOBILIZATION |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K933227 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-01-24 |