MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2013-08-02 for THERABITE JAW REHABILITATION SYSTEM TH001 manufactured by Atos Medical Ab.
[20647999]
The patient has used the therabite system since (b)(6) 2012. In (b)(6) 2013, she experienced sudden onset of finger numbness, pain and reduced range of motion in her right hand. When these issues with her hand failed to resolve she sought care from a hand surgeon specialist. According to the patient it was the hand surgeon? S opinion that the repetitive gripping motion used to operate the therabite system could have caused the problems with her hand. Unfortunately the problems with her right hand failed to respond to treatments and in (b)(6) 2013, she underwent surgery on her hand. Currently the patient is still experiencing numbness, tingling and reduced range of motion and reduced strength in her right hand.
Patient Sequence No: 1, Text Type: D, B5
[20867815]
Investigation: the device is a fairly uncomplicated handheld exercise tool. Our sales rep. Thoroughly inspected the device at the patients home during a visit and found that it worked as intended. According to the patient her surgeon stated that the therabite system was, - all ready to go-, and she was advised to perform 160 repetitions daily, performed in sets of 10 throughout the day. Additionally none of her two jaw specialists instructed her about the function of the white clamp/hand aid that is included in the therabite system, nor did she read the ifu where this accessory is clearly described. Conclusion: the product functions as intended and the event was caused by the user/clinician not following the instructions for use. The exercise regime recommended by the clinician is very extensive and beyond what is recommended in the ifu. The use of the hand-aid according to ifu would have been beneficial for the patient especially on such an extensive exercise regime. An in-service by the sales representative with the oral surgeon is pending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8032044-2013-00005 |
| MDR Report Key | 3260843 |
| Report Source | 04,07 |
| Date Received | 2013-08-02 |
| Date of Report | 2013-02-07 |
| Date of Event | 2013-05-01 |
| Date Mfgr Received | 2013-06-11 |
| Date Added to Maude | 2013-08-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR FERENC DAHNER |
| Manufacturer Street | PO-BOX 183 |
| Manufacturer City | HORBY, SE-242 22 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-242 22 |
| Manufacturer Phone | 415 19800 |
| Manufacturer G1 | ATOS MEDICAL AB |
| Manufacturer Street | PO BOX 183 |
| Manufacturer City | HORBY, SE-242 2 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | SE-242 22 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERABITE JAW REHABILITATION SYSTEM |
| Generic Name | JAW EXERCISER |
| Product Code | ION |
| Date Received | 2013-08-02 |
| Model Number | TH001 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATOS MEDICAL AB |
| Manufacturer Address | PO BOX 183 HORBY, SE-242 2 SW SE-242 22 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-08-02 |