MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 1997-09-11 for DENTAL DAM MEDIUM GREEN 101-0171 (SETTEIN) manufactured by Coltene/whaledent Inc.
[15038063]
Pt had to be rushed to hospital 45 minutes after receiving an injection of lidocaine with rubber dam in place was received on september 1997. Source did not actually speak to dr but to someone in his office. Source told me that pt was ok, and that source did not know the concentration of the lidocaine injection. (at this point there was no clear cut indication as to what caused a reaction. ) this was the first time dr treated this pt. Dr mentioned that pt had received prior dental treatment but not by him and he did not know by whom. Pt was unaware of any allergies. Dr told co that after placing the rubber dam and injecting with 2% pt exhibited facial swelling and breathing difficulties and was rushed to hospital. Date of occurrence was 7/17/97. According to dr, pt did not go into anaphylactic shock and was ok soon thereafter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2416455-1997-00002 |
| MDR Report Key | 119480 |
| Report Source | 05,08 |
| Date Received | 1997-09-11 |
| Date of Event | 1997-07-17 |
| Date Mfgr Received | 1997-09-01 |
| Device Manufacturer Date | 1996-06-01 |
| Date Added to Maude | 1997-09-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTAL DAM |
| Generic Name | ISOLATION/BARRIER PRODUCT |
| Product Code | EIE |
| Date Received | 1997-09-11 |
| Model Number | MEDIUM GREEN |
| Catalog Number | 101-0171 (SETTEIN) |
| Lot Number | NA |
| ID Number | EXP 6/99 |
| Device Expiration Date | 1999-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 117131 |
| Manufacturer | COLTENE/WHALEDENT INC |
| Manufacturer Address | 750 CORPORATE DR MAHWAH NJ 074302009 US |
| Baseline Brand Name | DENTAL DAM |
| Baseline Generic Name | ISOLATION/BARRIER PRODUCT |
| Baseline Model No | MEDIUM GREEN |
| Baseline Catalog No | 101-0171 (SCHEIN) |
| Baseline ID | EXP 6/99 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-09-11 |