MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-02-01 for SINGLE FUNCTION HANDPIECE ABC ELECTRODE 130344 manufactured by Consolidated Medical Equipment.
[134742662]
The reported device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[134742663]
The distributor in (b)(4) rejected one (1) 130344, single function handpiece electrode, due to an "insufficient heat seal". In this instance, there was no patient involvement as the packaging anomaly was discovered during incoming inspection prior to distribution to an end-user. This report is being raised based on device malfunction with potential for injury with reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2019-00026 |
| MDR Report Key | 8296817 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-02-01 |
| Date of Report | 2019-03-07 |
| Date Mfgr Received | 2019-02-06 |
| Device Manufacturer Date | 2018-04-20 |
| Date Added to Maude | 2019-02-01 |
| 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 | MELANIE HANSEN |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Street | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA 31136 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 31136 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE FUNCTION HANDPIECE ABC ELECTRODE |
| Generic Name | APPARATUS, ELECTROSURGICAL |
| Product Code | HAM |
| Date Received | 2019-02-01 |
| Returned To Mfg | 2019-01-31 |
| Catalog Number | 130344 |
| Lot Number | 201804204 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Address | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA 31136 MX 31136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-01 |