MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-09 for SHARPLASE DUAL EFFECT 25389 manufactured by Sharplin Lasers, Inc..
[14464]
Laser tip broke off during surgery and embedded in uterus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 26363 |
| MDR Report Key | 26363 |
| Date Received | 1995-08-09 |
| Date of Report | 1995-05-02 |
| Date of Event | 1995-04-13 |
| Date Facility Aware | 1995-04-13 |
| Report Date | 1995-05-02 |
| Date Reported to Mfgr | 1995-05-02 |
| Date Added to Maude | 1995-10-03 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHARPLASE DUAL EFFECT |
| Generic Name | 600 BARE FIBRE |
| Product Code | HHR |
| Date Received | 1995-08-09 |
| Model Number | 25389 |
| Lot Number | 305 392 |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 27037 |
| Manufacturer | SHARPLIN LASERS, INC. |
| Manufacturer Address | ONE PEARL COURT ALLENDALE NJ 07401 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-08-09 |