MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-08-07 for VAGINAL SPECULA DISPOSABLE, MEDIUM VAG.SPEC.DISP.MD 4912 (WE ASSUME) manufactured by Dynarex Corp..
[20736412]
(b)(6) from the (b)(6) dept of health and environmental control reported on form fda 3500 that on 2 incidents, (b)(6) 2012, our medium vaginal speculum product malfunctioned. The incidents consist of inserting the product into the vagina, after which a small piece of plastic broke off the speculum as the nurse was beginning to open the speculum in the vagina. The nurse was hit on the chin for the 1st occurrence and on the cheek for the second occurrence. The nurse's skin was not broken; she was wearing glasses and ppe. The client was not injured. On form 3500 reported by (b)(6), the item number and lot number are not provided.
Patient Sequence No: 1, Text Type: D, B5
[20967463]
(b)(4) devices from old lot number (22909 from (b)(4)) and (b)(4) devices from new lot number (23717, from same company) were tested in a simulated use technique. All devices did not fail or break. We have sent a f/u letter and 2 reminders. Unfortunately , (b)(6) has not cooperated with dynarex in supplying the exact item number, lot number, in supplying samples, as well as the medwatch report number for this complaint. We have inspected old lot number and new lot number samples for this product, which we believe is item (b)(4) and we are unable to verify this complaint. In view of above, our investigation has stopped, for we have received no response from the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2431014-2012-01670 |
| MDR Report Key | 2705389 |
| Report Source | 06,07 |
| Date Received | 2012-08-07 |
| Date of Report | 2012-08-02 |
| Date of Event | 2012-06-12 |
| Date Facility Aware | 2012-07-23 |
| Report Date | 2012-08-02 |
| Date Reported to FDA | 2012-07-13 |
| Date Reported to Mfgr | 2012-07-23 |
| Date Added to Maude | 2012-11-27 |
| 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 | 10 GLENSHAW ST. |
| Manufacturer City | ORANGEBURG NY 10962 |
| Manufacturer Country | US |
| Manufacturer Postal | 10962 |
| Manufacturer Phone | 8453658200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAGINAL SPECULA DISPOSABLE, MEDIUM |
| Generic Name | MEDIUM VAGINAL SPECULUM |
| Product Code | HIB |
| Date Received | 2012-08-07 |
| Model Number | VAG.SPEC.DISP.MD |
| Catalog Number | 4912 (WE ASSUME) |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DYNAREX CORP. |
| Manufacturer Address | ORANGEBURG NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-07 |