MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-09-12 for 1503832 manufactured by Baxter Apatech Ltd.
[25612179]
(b)(4). The event occurred on and the ostene was implanted on an unreported date in (b)(6) 2015. (b)(6) should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[25612180]
It was reported that a patient started re-bleeding within 1-2 hours after application of ostene. The patient was undergoing a sternotomy surgery. The site of application was not reported. It was reported that 20 minutes after the ostene was applied, the ostene started to dissolve. Additionally, it was reported that the dissolution occurred even faster while the cardiovascular surgeon was performing irrigation. It was reported that the product was not warmed to body temperature and further described as the product was not warmed prior to use and it's condition wasn't different than usual. The amount of blood loss, medical intervention, and the patient outcome was not reported. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[26525116]
(b)(4). The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2015-35707 |
| MDR Report Key | 5072984 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-09-12 |
| Date of Report | 2015-09-23 |
| Date Mfgr Received | 2015-09-17 |
| Date Added to Maude | 2015-09-12 |
| 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 | KINGA ALMASAN |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER APATECH LTD |
| Manufacturer Street | 370 CENTENNIAL AVE |
| Manufacturer City | HERTFORDSHIRE |
| Manufacturer Country | UK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | WAX,BONE |
| Product Code | MTJ |
| Date Received | 2015-09-12 |
| Catalog Number | 1503832 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER APATECH LTD |
| Manufacturer Address | 370 CENTENNIAL AVE HERTFORDSHIRE UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-12 |