MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-11-12 for TYPE-S OVERLAY 20-CFHN-SUB2 manufactured by Medtec, Inc. (dba. Civco Medical Solutions).
[1083892]
One therapist was in the room and was at the foot end of the table. When pt went to lay down they went back really fast causing the board to pop off the lok-bar and from there the board and couchtop rubbed together and the board slid right of the end of the table. The pt fell back head first, bumped their head. Board was initially locked down with the lok-bar and the velcro strap but not sure if the strap was tied tight as it should be. Hospital reported pt was negative for a concussion and blurred vision. Four plain view x-rays of the right shoulder were taken showing a shoulder sprain, torn ligaments, and a small ac separation. Pt given a sling and instructed to wear for 2 days allowing shoulder to heal if protected. Pt was not given any additional pain meds as he has a prescription from the radiation department for roxanol.
Patient Sequence No: 1, Text Type: D, B5
[8437360]
The belt was not properly used to secure the overlay to the table. Device was not available for eval. Reviewing clinician's description of event and medical device report filed with fda by the clinic, it was determined that the device was used against the provided instruction for use. The instruction provided with the device contained warnings to: not allow the pt to reposition themself. Do not use the lok-bar to secure positioning devices. A note on the board also instructs "attach overlay to table using strap before positioning the pt". No additional action planned. Device not used as intended. Clinic confirmed that they will not extend the overlay and provide pictures of their future setup/use. Initial info provided by user did not meet requirements of a medical device reporting incident. Additional info provided on 10/10/2008 via medwatch form initiated by ser and email info provided by user on 10/17/08 detailed assessment of injuries.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1932738-2008-00002 |
| MDR Report Key | 1413545 |
| Report Source | 06 |
| Date Received | 2008-11-12 |
| Date of Report | 2008-11-10 |
| Date of Event | 2008-10-06 |
| Date Mfgr Received | 2008-10-10 |
| Device Manufacturer Date | 2008-08-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TYPE-S OVERLAY |
| Generic Name | TYPE-S OVERLAY |
| Product Code | IWY |
| Date Received | 2008-11-12 |
| Model Number | 20-CFHN-SUB2 |
| Catalog Number | 20-CFHN-SUB2 |
| Lot Number | M031900 |
| 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 | 2008-11-12 |