MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-02-12 for HI PWR DISPOSBL GRNDING PAD DGPHP manufactured by Covidien Lp.
[4338631]
The customer reported that prior to use the doctor noticed the termination cover (cover over the wire/pad connection) was missing. Another grounding pad was used. There was no pt involvement.
Patient Sequence No: 1, Text Type: D, B5
[11583372]
(b)(4). To date, the incident sample has not been received for eval. If the sample is received, or if add'l info pertinent to the incident is obtained, a f/u report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2014-00106 |
| MDR Report Key | 3700294 |
| Report Source | 01,05,06 |
| Date Received | 2014-02-12 |
| Date of Report | 2014-01-14 |
| Date of Event | 2014-01-09 |
| Date Mfgr Received | 2014-01-14 |
| Date Added to Maude | 2014-05-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON MURPHY, SR., DIR., PMV |
| Manufacturer Street | 5920 LONGBOW DR. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 203492526 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HI PWR DISPOSBL GRNDING PAD |
| Generic Name | RF ABLATION GROUNDING PAD |
| Product Code | ODR |
| Date Received | 2014-02-12 |
| Catalog Number | DGPHP |
| 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 |
| Manufacturer Address | 5920 LONGBOW DR. BOULDER CO 80301 US 80301 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-12 |