MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-29 for JARIT UNK manufactured by Jarit Surgical.
[805956]
During procedure, weighted speculum lacerated pt's vagina, requiring suturing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 988489 |
| MDR Report Key | 988489 |
| Date Received | 2007-08-29 |
| Date of Report | 2007-06-05 |
| Date of Event | 2007-05-24 |
| Date Facility Aware | 2007-05-24 |
| Report Date | 2007-06-05 |
| Date Reported to Mfgr | 2007-06-05 |
| Date Added to Maude | 2008-01-31 |
| 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 | 3 |
| 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 | JARIT |
| Generic Name | WEIGHTED SPECULUM |
| Product Code | HDF |
| Date Received | 2007-08-29 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Device Expiration Date | 2001-01-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 956329 |
| Manufacturer | JARIT SURGICAL |
| Manufacturer Address | * HAWTHORNE NY * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-08-29 |