MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-06-22 for BONE WAX BW25G manufactured by Covidien North Haven - Mfg.
[78226446]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[78226447]
According to the reporter, the product had a bad texture and bad support in the bone with difficult use, resulting to an absence of haemostatic effect. Another surgery had been necessary to resolve the case. The patient is alive. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[106058787]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[106058788]
According to the reporter: during spin surgery, the product had a bad texture and bad support in the bone with difficult use, resulting to an absence of haemostatic effect. There was an appearance of a hematoma and another surgery had been necessary to resolve the case. The patient is alive. No additional information was provided the current patient status is ok.
Patient Sequence No: 1, Text Type: D, B5
[109144607]
Evaluation summary: post market vigilance (pmv) led an evaluation of one device. A review of the manufacturing and quality records for this lot found no reports relating to dry or crumbling product. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2017-05853 |
| MDR Report Key | 6661905 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-06-22 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-05-17 |
| Date Mfgr Received | 2017-12-05 |
| Date Added to Maude | 2017-06-22 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 60 MIDDLETOWN AVENUE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN NORTH HAVEN - MFG |
| Manufacturer Street | 195 MCDERMOTT ROAD |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BONE WAX |
| Generic Name | WAX,BONE |
| Product Code | MTJ |
| Date Received | 2017-06-22 |
| Returned To Mfg | 2017-07-03 |
| Model Number | BW25G |
| Catalog Number | BW25G |
| Lot Number | 16041458 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN NORTH HAVEN - MFG |
| Manufacturer Address | 195 MCDERMOTT ROAD NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2017-06-22 |