MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-03-05 for ROCHESTER MEDICAL 63914 manufactured by Rochester Medical.
[592414]
Customer states he has used rochester medical antibacterial intermittent catheter (item # 63914) for 5 yrs. In the last year, he states he has had some catheters with a sharp edge on them. He states that he has been seen in the er and by his urologist 2 times with internal injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2007-00001 |
| MDR Report Key | 830354 |
| Report Source | 04 |
| Date Received | 2007-03-05 |
| Date of Report | 2007-03-05 |
| Date of Event | 2007-02-27 |
| Date Mfgr Received | 2007-02-27 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2007-03-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PRASHANTH PRABHAKAR |
| Manufacturer Street | ONE ROCHESTER MEDICAL DR |
| Manufacturer City | STEWARTVILLE MN 55976 |
| Manufacturer Country | US |
| Manufacturer Postal | 55976 |
| Manufacturer Phone | 5075339600 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROCHESTER MEDICAL |
| Generic Name | ANTIBACTERIAL INTERMITTENT URINARY CATH |
| Product Code | EXJ |
| Date Received | 2007-03-05 |
| Model Number | 63914 |
| Catalog Number | 63914 |
| Lot Number | 53603361 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 817731 |
| Manufacturer | ROCHESTER MEDICAL |
| Manufacturer Address | * STEWARTVILLE MN * US |
| Baseline Brand Name | ROCEHSTER MEDICAL |
| Baseline Generic Name | ANTIBACTERIAL INTERMITTENT URINARY CATH |
| Baseline Model No | 63914 |
| Baseline Catalog No | 63914 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-03-05 |