MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2011-07-28 for HI PWR DISPOSBL GRNDING PAD DGPHP manufactured by Covidien Lp, (valleylab).
[20791130]
The customer reported there were several black corrosion spots on the pads when unpacking. The pad was not used. Initial evaluation of the returned sample found the foil was degraded and the pad showed no resistance.
Patient Sequence No: 1, Text Type: D, B5
[20909454]
(b)(4). The incident device has been received and is under evaluation. When the device evaluation is complete, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2011-00599 |
| MDR Report Key | 2198597 |
| Report Source | 01,06 |
| Date Received | 2011-07-28 |
| Date of Report | 2011-07-20 |
| Date of Event | 2011-06-15 |
| Date Mfgr Received | 2011-07-20 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2011-09-26 |
| 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 |
| Reporter Occupation | UNKNOWN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| 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 | HI PWR DISPOSBL GRNDING PAD |
| Generic Name | PATIENT RETURN ELECTRODE |
| Product Code | ODR |
| Date Received | 2011-07-28 |
| Returned To Mfg | 2011-07-13 |
| Catalog Number | DGPHP |
| Lot Number | 193939 |
| Device Expiration Date | 2013-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-07-28 |