MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2009-03-06 for TYPE-S EXTENSION 20-CFHN-SUB2-V manufactured by Medtec, Inc (dba. Civco Medical Solutions).
[1051048]
The patient was sitting on the couch and was instructed by a staff member to move toward the head of the bed. To balance themselves, the patient grabbed onto the extension, as they moved into position the extension lifted off causing the patient to flip off the end of the bed head first onto the floor. A staff member who tried to grab the patient was also injured. Patient received a bruise on the head. Patient and staff member did not receive treatment and are now fine.
Patient Sequence No: 1, Text Type: D, B5
[8222313]
Method: device was not available for evaluation. The distributor's description of events was reviewed. Results: per distributor, the extension had a very loose fit and could move up and down extremely easily. The type-s extension was not secure prior to use. The clinician allowed the patient to reposition themselves incorrectly, which directly caused detachment. Conclusion: it was determined that the device was used against the provided instruction for use. Instructions for the type-s extension contained warnings to: not allow the patient to reposition themselves. Ensure device is secure prior to use. No additional action planned. Device not used as intended. Replacement parts sent to distributor to ensure a proper fit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932738-2009-00001 |
| MDR Report Key | 1338177 |
| Report Source | 01,08 |
| Date Received | 2009-03-06 |
| Date of Report | 2009-03-06 |
| Date of Event | 2009-02-09 |
| Date Mfgr Received | 2009-02-09 |
| Date Added to Maude | 2010-02-02 |
| 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. |
| Manufacturer City | ORANGE CITY IA 51041 |
| Manufacturer Country | US |
| Manufacturer Postal | 51041 |
| Manufacturer Phone | 7127378688 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TYPE-S EXTENSION |
| Generic Name | TYPE-S EXTENSION |
| Product Code | IWY |
| Date Received | 2009-03-06 |
| Model Number | 20-CFHN-SUB2-V |
| Catalog Number | 20-CFHN-SUB2-V |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTEC, INC (DBA. CIVCO MEDICAL SOLUTIONS) |
| Manufacturer Address | 1401 8TH ST. S.E. ORANGE CITY IA 51041 US 51041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-06 |