MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-02-15 for OZ TWH 99 DBC2 8888411009 manufactured by Covidien.
[2494068]
It was reported to covidien on (b)(6) 2012, that a customer had an issue with a peritoneal dialysis (pd) catheter. The customer states there was a case of catheter material intolerance and infection of a female pt following treatment of pd solution through the dialysis catheter. The physician stated the pt developed an irritated area at the catheter exit site.
Patient Sequence No: 1, Text Type: D, B5
[9654167]
Submit date: (b)(4) 2012. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317749-2012-00046 |
| MDR Report Key | 2469313 |
| Report Source | 01,06 |
| Date Received | 2012-02-15 |
| Date of Report | 2012-01-26 |
| Report Date | 2012-01-26 |
| Date Reported to Mfgr | 2012-01-26 |
| Date Mfgr Received | 2012-01-26 |
| Date Added to Maude | 2012-04-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | EDWARDS ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 5439 STATE ROUTE 40 |
| Manufacturer City | ARGYLE NY 12809 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12809 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OZ TWH 99 DBC2 |
| Generic Name | DIALYSIS CATHETER |
| Product Code | FKO |
| Date Received | 2012-02-15 |
| Model Number | 8888411009 |
| Catalog Number | 8888411009 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 5439 STATE ROUTE 40 ARGYLE NY 12809 US 12809 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-02-15 |