MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-12-09 for CAUTERY HIGH TEMP FINE TIP AA01 manufactured by Bovie Medical Corporation.
[61863870]
Distributer received a box of 9 of 10 cauteries with open pouch. Cauteries model aa01 sterile lot 0816j lot # 2016-08-06. The returned product was inspected and it was confirmed that the pouched units were unsealed. No additional complaints have been received for this catalog number aa01 manufacturing lot number 2016-08-06, sterile lot 0816j. Review of the batch record showed no non-conformance noted during the pouching process, packaging or qc inspection processes. Employees were made aware of the event and the sealing and packaging employees were instructed to assure adequate handling and separation of unsealed pouches.
Patient Sequence No: 1, Text Type: N, H10
[61863871]
Customer received a box with 9 of 10 unsealed pouches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007593903-2016-00012 |
| MDR Report Key | 6157513 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-12-09 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-11-11 |
| Date Mfgr Received | 2016-11-11 |
| Device Manufacturer Date | 2016-08-25 |
| Date Added to Maude | 2016-12-09 |
| 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 | JULIE MCDONALD |
| Manufacturer Street | 5115 ULMERTON ROAD |
| Manufacturer City | CLEARWATER FL 337604004 |
| Manufacturer Country | US |
| Manufacturer Postal | 337604004 |
| Manufacturer Phone | 7278038554 |
| Manufacturer G1 | BOVIE MEDICAL CORPORATION |
| Manufacturer Street | 5115 ULMERTON ROAD |
| Manufacturer City | CLEARWATER FL 337604004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 337604004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAUTERY HIGH TEMP FINE TIP |
| Generic Name | AA01 |
| Product Code | HQP |
| Date Received | 2016-12-09 |
| Returned To Mfg | 2016-11-17 |
| Catalog Number | AA01 |
| Lot Number | 0816J |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOVIE MEDICAL CORPORATION |
| Manufacturer Address | 5115 ULMERTON ROAD CLEARWATER FL 337604004 US 337604004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-09 |