MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2010-04-16 for POLYHESIVE II RETURN ELECTRODE E7507 manufactured by Covidien Lp (valleylab).
[1641555]
The customer reported that during preparation for the surgical procedure, the electrode was found to have a damaged cord. The copper wire in the cord was exposed. The device was not used.
Patient Sequence No: 1, Text Type: D, B5
[8543222]
(b)(4). The return of the incident sample has been requested. To date it has not been received for evaluation. If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2010-00273 |
| MDR Report Key | 1664533 |
| Report Source | 01,06 |
| Date Received | 2010-04-16 |
| Date of Report | 2010-03-25 |
| Date of Event | 2010-03-10 |
| Date Mfgr Received | 2010-03-25 |
| Date Added to Maude | 2010-07-06 |
| 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 | 0 |
| Manufacturer Contact | KIM SCHWARZ, MANAGER |
| Manufacturer Street | 5920 LONGBOW DR. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306245 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYHESIVE II RETURN ELECTRODE |
| Generic Name | REM PATIENT RETURN ELECTRODE |
| Product Code | ODR |
| Date Received | 2010-04-16 |
| Catalog Number | E7507 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP (VALLEYLAB) |
| Manufacturer Address | 5920 LONGBOW DR. BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-16 |