MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-23 for ANALYER CABLE 12 FT DISPOSABLE S-101-97-12(1) manufactured by Remington Medical, Inc..
[115062863]
Product package with two extra pins in the packet. Pins were in the rubber covering and discovered prior to pt exposure but could have dropped into sterile field. Used in electrophysiology lab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078531 |
| MDR Report Key | 7713996 |
| Date Received | 2018-07-23 |
| Date of Report | 2018-07-20 |
| Date of Event | 2018-07-20 |
| Date Added to Maude | 2018-07-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ANALYER CABLE 12 FT DISPOSABLE |
| Generic Name | CABLE TRANSDUCER AND ELECTRODE |
| Product Code | DSA |
| Date Received | 2018-07-23 |
| Model Number | S-101-97-12(1) |
| Lot Number | 1725718 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REMINGTON MEDICAL, INC. |
| Manufacturer Address | ALPHARETTA GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-23 |