MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2012-04-09 for DUKAL VAGINAL SPECULUM SM 6550 manufactured by Gongdong.
[16750731]
Complainant stated: the open/close mechanism of the 6550 vaginal speculum broke during a pt exam. The open/close mechanism was located outside of the pt. There were no injuries and no medical intervention was needed. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[17042305]
Investigation could not be performed as product was discarded by user. Lot number could not be confirmed for batch review. Defect could not be confirmed. There have been no other complaints of this type for this product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2435946-2012-00001 |
| MDR Report Key | 2577600 |
| Report Source | 01 |
| Date Received | 2012-04-09 |
| Date of Report | 2012-04-02 |
| Date of Event | 2012-03-23 |
| Date Facility Aware | 2012-03-23 |
| Report Date | 2012-04-02 |
| Date Mfgr Received | 2012-03-23 |
| Date Added to Maude | 2012-08-01 |
| 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 Street | NO. 10 BEIYUAN AVE ECONOMIC DEVELOPMENT ZONE |
| Manufacturer City | HUANGYAN TAIZHOU ZHEJIANG |
| Manufacturer Country | CH |
| Manufacturer Phone | 684081066 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUKAL VAGINAL SPECULUM SM |
| Generic Name | VAGINAL SPECULUM |
| Product Code | HIB |
| Date Received | 2012-04-09 |
| Model Number | 6550 |
| Catalog Number | 6550 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GONGDONG |
| Manufacturer Address | NO. 10 BEIYUAN AVE ECONOMIC DEVELOPMENT ZONE HUANGYAN TAIZHOU ZHEJIANG CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-09 |