MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-07-01 for MEDTEC DISPOSABLE TYPE-S THERMOPLASTIC MASK MT-APSID-27-32 AT-APSID-27-32 manufactured by Medtec.
[17019464]
Customer stated they had pt where they could not remove disposable type-s thermoplastic. Pt was event in distress. The department received assistance from another department for removal of the thermoplastic. The pt had a tracheotomy tube which was removed from the pt when the disposable thermoplastic was finally removed from the type-s. The trach was stuck to the thermoplastic. Thermoplastic was not cut away from trach. It was stretched over trach. Pt is fine. Pt will be visiting facility next week for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932738-2005-00010 |
| MDR Report Key | 619622 |
| Report Source | 05 |
| Date Received | 2005-07-01 |
| Date of Report | 2005-07-01 |
| Date of Event | 2005-06-24 |
| Date Mfgr Received | 2005-06-24 |
| Device Manufacturer Date | 2005-03-01 |
| Date Added to Maude | 2005-07-07 |
| 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 | 0 |
| Manufacturer Street | 1401 8TH ST S.E. PO BOX 320 |
| Manufacturer City | ORANGE CITY IA 51041 |
| Manufacturer Country | US |
| Manufacturer Postal | 51041 |
| Manufacturer Phone | 7127378688 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTEC DISPOSABLE TYPE-S THERMOPLASTIC MASK |
| Generic Name | RADIOGRAPHIC HEAD HOLDER |
| Product Code | IWY |
| Date Received | 2005-07-01 |
| Model Number | MT-APSID-27-32 |
| Catalog Number | AT-APSID-27-32 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 609302 |
| Manufacturer | MEDTEC |
| Manufacturer Address | * ORANGE CITY IA * US |
| Baseline Brand Name | DISPOSIBLE TYPE-S MASK |
| Baseline Generic Name | RADIOGRAPHIC HEAD HOLDER |
| Baseline Model No | MT-APSID-27-32 |
| Baseline Catalog No | MT-APSID-27-32 |
| Baseline ID | RELOADABLE THER |
| Baseline Device Family | PATIENT POSITIONING AND IMMOBILIZATION, UNI-FRAME, TYPE-S MASK, DISPOSABLE |
| 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 | 2005-07-01 |