MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-26 for BUGBEE EET107B manufactured by Greenwald Surgical Co..
[658348]
Pt admitted for left ureterocele repair. This was completed with the bugbee electrode (through the ped. Cystoscope), pt discharged and returned 240 later with pain and up wbc, retained urine, signs of peritonitis. Pt transferred to hosp in 2002. There they determined that the tip of the bugbee had broken off and was imbedded in the bladder wall. Pt required open surgery to retrieve the tip. Pt then had uneventful recovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002846 |
| MDR Report Key | 874359 |
| Date Received | 2007-06-26 |
| Date of Report | 2007-06-26 |
| Date of Event | 2007-04-29 |
| Date Added to Maude | 2007-07-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BUGBEE |
| Generic Name | LASER TIP |
| Product Code | LNK |
| Date Received | 2007-06-26 |
| Model Number | EET107B |
| ID Number | RED 4 FR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 855492 |
| Manufacturer | GREENWALD SURGICAL CO. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2007-06-26 |