MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-01-21 for PROGUARD PROGUARD RR-1,PROGUA NA manufactured by Protech Leaded Eyewear, Inc..
[338348]
Add'l info rec'd 5/27/04: there is very little for mfr to go on to give a conclusive answer, relative to the stated malfunction. Unfortunately, the only info on the product is the trade name. There is no lot#, expiration date, nor was mfr given a sample back to determine a malfunction and cause if there was one. The relevant tests and laboratory data has been crossed out, therefore mfr is not able to confer with this laboratory to determine how bad the stated malfunction was. Mfr does maintain a cross section of all the lot# produced, but again without knowing what lot# was used in this report mfr cannot go back to samples and test for abnormalities. Mfr can only do random sample test of the attenuative value of gloves mfr has now, mfr will submit samples to an independent laboratory and send the follow up attenuative results when it is done. Mfr would like to also mention, that the out comes due to adverse event are greatly overstated. If a radiation reducing glove (any radiation reducing glove) failed to protect at the level stated, during one user or in fact a number of uses) hospitalization, disability and permanent impairment would not occur.
Patient Sequence No: 1, Text Type: D, B5
[19159868]
X-ray radiation reducing gloves to be used in all hosps during fluoroscopic procedure to protect dr's hands from scattered radiation do not attenuate scattered radiation as claimed verified by osha report of 12. 30. 03.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1030926 |
| MDR Report Key | 508868 |
| Date Received | 2004-01-21 |
| Date of Report | 2004-01-21 |
| Date Added to Maude | 2004-02-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROGUARD |
| Generic Name | RADIATION REDUCING GLOVES BASED ON LEAD |
| Product Code | IWP |
| Date Received | 2004-01-21 |
| Model Number | PROGUARD RR-1,PROGUA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 497815 |
| Manufacturer | PROTECH LEADED EYEWEAR, INC. |
| Manufacturer Address | 4087 BURNS RD PALM BEACH GARDENS FL 33410 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2004-01-21 |