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 2017-08-11 for FLEXI-PET ADJUSTABLE HANDLE SET K-MPH-1000 manufactured by Cook Inc.
[82473475]
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[82473476]
The user facility reported after receiving the flexi-pet adjustable handle set, it was observed to have the same flaws that were found in the previous one that this product was a replacement for. As reported, there is also "oil" in the front part of this product. These issues were discovered prior to patient contact. There was no patient involvement with this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-02301 |
| MDR Report Key | 6787479 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-11 |
| Date of Report | 2018-03-06 |
| Date of Event | 2017-08-08 |
| Date Mfgr Received | 2018-02-14 |
| Device Manufacturer Date | 2016-12-01 |
| Date Added to Maude | 2017-08-11 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXI-PET ADJUSTABLE HANDLE SET |
| Generic Name | MQH ASSISTED REPRODUCTION MICROTOOLS |
| Product Code | MQH |
| Date Received | 2017-08-11 |
| Catalog Number | K-MPH-1000 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-11 |