MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-20 for BEAVER ACCU-TEMP HIGH TEMPERATURE CAUTER, 2 INCH SHAFT WITH FINE TIP (10/BOX) 8445000 manufactured by Beaver-visitec International, Inc.
[121566436]
Component missing
Patient Sequence No: 1, Text Type: N, H10
[121566437]
Customer complaint was received alleging that two accu-temp high temperature cautery devices were found prior to use, each sealed in its tyvek-mylar pouch. One unit appeared to have evidence of a partially melted white cap and a breach in the sterile pouch. The other product packaging contained a breach in the sterile pouch only which appeared to be caused by the unit with the melted cap. The customer stated no other damage was observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1211998-2018-00002 |
| MDR Report Key | 7896738 |
| Date Received | 2018-09-20 |
| Date of Report | 2018-07-15 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-05-24 |
| Date Added to Maude | 2018-09-20 |
| 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 | MRS ROBIN ROWE |
| Manufacturer Street | 500 TOTTEN POND RD 10 CITYPOINT |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 2698065779 |
| Manufacturer G1 | BEAVER-VISITEC INTERNATIONAL, INC |
| Manufacturer Street | 500 TOTTEN POND RD 10 CITYPOINT |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02451 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BEAVER ACCU-TEMP HIGH TEMPERATURE CAUTER, 2 INCH SHAFT WITH FINE TIP (10/BOX) |
| Generic Name | THERMAL CAUTERY UNIT |
| Product Code | HQP |
| Date Received | 2018-09-20 |
| Catalog Number | 8445000 |
| Lot Number | 6002809 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEAVER-VISITEC INTERNATIONAL, INC |
| Manufacturer Address | 500 TOTTEN POND RD 10 CITYPOINT WALTHAM MA 02451 US 02451 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-20 |