MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-06-26 for SAFEHIP AIRX 336650-05.01.F62 3366 manufactured by Tytex Slovakia S.r.o..
[15177422]
The user of the product fell (slipped from a low chair) and sustained a fractured neck of femur (hip fracture) whilst the product was insitu.
Patient Sequence No: 1, Text Type: D, B5
[15635752]
We have had insufficient evidence obtained from the facility where the incident occurred to determine whether the device may have contributed to the incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006121457-2011-00001 |
| MDR Report Key | 3899510 |
| Report Source | 99 |
| Date Received | 2014-06-26 |
| Date of Report | 2014-06-25 |
| Date of Event | 2011-09-15 |
| Date Reported to Mfgr | 2011-10-26 |
| Date Mfgr Received | 2011-10-26 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2014-06-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | CHEMLONSKA 1 |
| Manufacturer City | HUMENNE 06601 |
| Manufacturer Country | LO |
| Manufacturer Postal | 06601 |
| Manufacturer Phone | 902944777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFEHIP AIRX |
| Generic Name | HIP PROTECTOR |
| Product Code | IQE |
| Date Received | 2014-06-26 |
| Returned To Mfg | 2011-11-01 |
| Model Number | 336650-05.01.F62 |
| Catalog Number | 3366 |
| Lot Number | 174310 |
| Device Expiration Date | 2015-10-15 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TYTEX SLOVAKIA S.R.O. |
| Manufacturer Address | CHEMLONSKA 1 HUMENNE 06601 LO 06601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-06-26 |