MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-04 for DENTAL DAM 5 X 5 LIGHT MED READY CUT DAM H00524 manufactured by Coltene/whaledent Inc..
[16005418]
It is unk if this single-use device was reprocessed and reused on a pt. The dental office was contacted to gather additional info but the info provided by the dental office did not include info in regards to reprocessed or reused devices. Due to the nature of this type of device it is highly unlikely to be reprocessed or reused. It is impossible to determine the exact nature of the allergic reaction. As noted in the original complaint the dental office also used latex gloves so the allergic reaction could have been caused by either the latex gloves or the dental dam or the combination of using both. Allergic reactions to the use of latex products is well known in the dental industry and the product is labeled with caution statements telling the end user the product contains natural rubber which may cause allergic reactions. The labeling was verified as being correct in its application and verbiage as specified in 21cfr 801. 437 user labeling for devices that contain natural rubber.
Patient Sequence No: 1, Text Type: N, H10
[16124796]
Office says they have had 2 of their pts with blistering and swelling on their lips caused by the dental dams. But they also use latex gloves. The dental office reports that both pts were healthy and normal condition before the event. The dental office reports the condition of both pts after the event as having blisters and swelling on the lips. The dental office reports when the (b)(6) came back to the office three days after the event for a f/u and after using neosporin and ice, the swelling went down. A subsequent visit that occurred five days after the event indicated the pt blistering was almost gone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2416455-2012-00001 |
| MDR Report Key | 2543142 |
| Report Source | 05 |
| Date Received | 2012-04-04 |
| Date of Report | 2012-04-03 |
| Date of Event | 2012-02-23 |
| Date Mfgr Received | 2012-03-08 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2012-08-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GLENN PERSELLO |
| Manufacturer Street | 235 ASCOT PARKWAY |
| Manufacturer City | CUYAHOGA FALLS OH 44223 |
| Manufacturer Country | US |
| Manufacturer Postal | 44223 |
| Manufacturer Phone | 3309168837 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTAL DAM 5 X 5 LIGHT MED READY CUT DAM |
| Generic Name | EIE - RUBBER DAM |
| Product Code | EIE |
| Date Received | 2012-04-04 |
| Returned To Mfg | 2012-03-29 |
| Catalog Number | H00524 |
| Lot Number | 036F3 |
| Device Expiration Date | 2014-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLTENE/WHALEDENT INC. |
| Manufacturer Address | CUYAHOGA FALLS OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-04 |