MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-01-15 for COUGAR LS 18X14X45 15-DEG LORD 189145614 manufactured by Medos International Sàrl Ch.
[188219973]
Without a lot number the device history records review could not be completed. Product was not returned. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[188219974]
It was reported that on (b)(6) 2019, the patient had spinal fusion surgery. Immediately after the surgery the patient felt good, but one week after, the patient was at the emergency room with an allergic reaction. He was given (b)(6) and symptoms improved. His condition has deteriorated and in pain every day. He had a prior surgery in the 1990's where stainless steel or titanium rods and screws were implanted in his hand and had to be removed because of allergic reaction that caused the surgery site not to heal. Upon removal of the implants, the hand healed. The current surgeon was notified of the issue with the prior surgery but insisted that materials had changed since the 1990's and the possibility of an adverse reaction were minuscule. Because of the patient urged the surgeon to get him allergy tested because of how he feels, he did put in an order and was tested, however, upon completion of the testing he was told he was tested for the wrong items. The patient have not heard back from anyone and now taking his healthcare into his own hands and would like to have independent allergy testing performed. The patient needs information from the company in order to do so. This is report 1 of 10 for (b)(4). This (b)(4) capture the 10 out of 12 devices reported/received and (b)(4) capture the other 2 out of 12 devices reported/received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00377 |
| MDR Report Key | 9590883 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-02 |
| Date Mfgr Received | 2020-01-02 |
| Date Added to Maude | 2020-01-15 |
| 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 | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | CHEMIN-BLANC 38 |
| Manufacturer City | LE LOCLE 02400 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 02400 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MEDOS INT SPINE |
| Manufacturer Street | CHEMIN BLANC 38 |
| Manufacturer City | LE LOCLE |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COUGAR LS 18X14X45 15-DEG LORD |
| Generic Name | POLYMERIC SPINAL FUSION CAGE |
| Product Code | MQP |
| Date Received | 2020-01-15 |
| Model Number | 189145614 |
| Catalog Number | 189145614 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDOS INTERNATIONAL SàRL CH |
| Manufacturer Address | CHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-15 |