MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-09-10 for UNK manufactured by Unk.
[20831810]
Per distributor, the customer expected to return the fiber for analysis. As of 8/30/2007, no device evaluation results are available and no conclusion can be drawn regarding root cause of the incident. A follow up mdr will be submitted of lumen's obtains additional information.
Patient Sequence No: 1, Text Type: N, H10
[20838176]
A patient was persistent 8ph, underwent a laser turp, the physician used a holmium laser to vaporize tissue around the bladder neck and surrounding areas. It was reported during the laser procedure. The patient suffered injury to his bladder resulting in additional surgeries resulting a loss of bladder requiring the use of urostomy bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2914019-2007-00029 |
| MDR Report Key | 909798 |
| Report Source | 04 |
| Date Received | 2007-09-10 |
| Date of Report | 2007-08-31 |
| Date of Event | 2007-08-15 |
| Date Mfgr Received | 2007-08-03 |
| Date Added to Maude | 2007-10-09 |
| 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 | 3 |
| Manufacturer Contact | CHRISTERAL CAPPE |
| Manufacturer Street | 5302 BETSY ROSS RD, |
| Manufacturer City | SANTA CLARA CA 95054 |
| Manufacturer Country | US |
| Manufacturer Postal | 95054 |
| Manufacturer Phone | 4087643290 |
| Manufacturer City | YOKNEAM IL |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | UNK |
| Product Code | LNK |
| Date Received | 2007-09-10 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 892138 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-09-10 |