MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-10-31 for KOALA SES-240 manufactured by Boston Scientific - Marlborough.
[125667537]
The complainant was unable to provide the suspect device lot number; therefore, the device manufacture dates is unknown. This is a non-sterile device with no expiration date. Mfg site name - endochoice. (b)(4). The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[125667538]
It was reported to boston scientific corporation on (b)(6) 2018 that a koala sponge was used for scope cleaning performed on an unknown date. According to the complainant, a technician experienced an allergic reaction while using the koala sponge. The technician was taken to the er for breathing issues, however no treatment was administered. The technician no longer works in the procedure or scope cleaning room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-02628 |
| MDR Report Key | 8024395 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-31 |
| Date of Report | 2018-01-26 |
| Date of Event | 2018-01-26 |
| Date Mfgr Received | 2018-01-26 |
| Date Added to Maude | 2018-10-31 |
| 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 Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOALA |
| Generic Name | GAUZE / SPONGE,NONRESORBABLE FOR EXTERNAL USE |
| Product Code | NAB |
| Date Received | 2018-10-31 |
| Model Number | SES-240 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - MARLBOROUGH |
| Manufacturer Address | 100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-10-31 |