MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-27 for PREMIUM VAGINAL SPECULUM manufactured by Mckesson Medical Surgical Inc..
[106897976]
Speculums shatter very easily, one broke while using on patient and found packages with damage speculum which had to be discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076837 |
| MDR Report Key | 7471951 |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-10 |
| Date of Event | 2018-04-02 |
| Date Added to Maude | 2018-04-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREMIUM VAGINAL SPECULUM |
| Generic Name | PREMIUM VAGINAL SPECULA |
| Product Code | HIB |
| Date Received | 2018-04-27 |
| Lot Number | 222017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MCKESSON MEDICAL SURGICAL INC. |
| Manufacturer Address | RICHMOND VA 21233 US 21233 |
| Brand Name | PREMIUM VAGINAL SPECULUM |
| Generic Name | PREMIUM VAGINAL SPECULA |
| Product Code | HIB |
| Date Received | 2018-04-27 |
| Lot Number | 222123 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MCKESSON MEDICAL SURGICAL INC. |
| Manufacturer Address | RICHMOND VA 21233 US 21233 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-27 |