MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-08-29 for * manufactured by Baur Und Haselbarth-chirurg Gmbh.
[7931177]
Distributor medwatch was received stating "during procedure, weighted speculum lacerated pt's vagina, requiring suturing. " as per the distributor the instrument was only available for inspection at the hospital's facility. A sales rep of the distributor visited the hospital and inspected the instrument visually and could confirm that there were no sharp edges on the instrument. Since neither the device was returned for eval nor a lot number was received, we were not able to perform an eval or a trend analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610621-2007-00001 |
| MDR Report Key | 988498 |
| Report Source | 08 |
| Date Received | 2007-08-29 |
| Date Mfgr Received | 2007-08-23 |
| Date Added to Maude | 2008-01-31 |
| 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 Street | SAUERBRUCHSTRASSE 7 |
| Manufacturer City | ELLERAU 25476 |
| Manufacturer Country | GM |
| Manufacturer Postal | 25476 |
| Manufacturer Phone | 10672091 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | HDF |
| Date Received | 2007-08-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 956333 |
| Manufacturer | BAUR UND HASELBARTH-CHIRURG GMBH |
| Manufacturer Address | SAUERBRUCHSTR. 7 ELLERAU GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-29 |