MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-10 for 5 X5 NON-LATEX DAM H09930 manufactured by Coltene/whaledent Inc..
[6836397]
Per dr. (b)(6) "on (b)(6) 2015, our office received a call at 12:45 from the patient's mother. She said left side of her daughter's face was swollen and red and itched and she had coughed once or twice. She came into the office, and her mandibular left side was swollen, red and looked like it was oozing fluids. We had completed an of composite on #19 earlier in the day. We put her on the pulse oximeter immediately. She was talking and not coughing. Her saturations remained between 95% and 99% the entire time she was at the office. We checked the inside of her mouth and there was no evidence of a cheek bite or hematoma. Her mother reported that when they were leaving the office after the appt, the patient mentioned that her cheek felt itchy. She went home, took a nap for an hour, and when she had awakened her face was then red and swollen and she coughed twice. The redness and swelling did go down some after taking 25mg of liquid benadryl. We also applied a very thin layer of benadryl cream to the area. I got the patient's pediatrician on the phone, explained what happened, and made an appt. I informed the patient's mother to call us immediately if there were any changes and to call the paramedics if she had any breathing issues. They prescribed a steroid and zyrtec for the patients to take. I checked on her multiple times on tuesday night by texting with her mother. She reported that she was sore, redder but the swelling had remained the same. I recommended some ibuprofen. She took some before she went to bed. I checked on her wednesday morning ((b)(6)2015). She said the area did not hurt. The patient went to school because her class had a zoo trip she wanted to attend. We arranged an appt. With a dermatologist on 05/14/2015. I received a call on (b)(6) from the dermatologist who examined the patient's face. They said it looked like superficial dermatitis. They recommended no more rubber dams for dental work. They said that the area should heal just fine without scarring, and recommended putting vaseline on the area to keep it moist and for her to use sunscreen when she was outside. I checked on the patient again on (b)(6) 2015. Her mother reports that she was doing well. The scab was gone and the area now just had a red mark where the scab used to be".
Patient Sequence No: 1, Text Type: D, B5
[13764870]
A request was sent to (b)(6) dental office to return the non-latex dental dam so that further investigation of the device in question could be performed. The dental office indicated that they would return to coltene the remaining 5x5 non-latex dental dam lot no. 203v. Coltene received from the dental office latex dam not the 5x5 non-latex dental dam lot no. 203v. The dental office was contacted again requesting the 5x5 non-latex dental dam lot no. 203v. The office informed coltene verbally on the phone the remaining 5x5 non-latex dental dam lot no. 203v was discarded and not available. Coltene has sent a formal request to the dental office asking the dental office for a documented statement. This needs to explained in detail that the dental office used the non-latex dam on the patient and then subsequently disposed the remaining non-latex dental dam that they had in the office. The details need to include the following product information: h09930, 5x5 non-latex dams, lot no. 203v. We also need a signature and date indicating when the document was signed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2416455-2015-00002 |
| MDR Report Key | 4911646 |
| Report Source | 06 |
| Date Received | 2015-07-10 |
| Date of Report | 2015-07-09 |
| Date of Event | 2015-05-12 |
| Date Facility Aware | 2015-05-12 |
| Report Date | 2015-07-10 |
| Date Reported to Mfgr | 2014-12-09 |
| Date Mfgr Received | 2015-06-11 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2015-07-15 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | DAN FILLER |
| Manufacturer Street | 235 ASCOT PARKWAY |
| Manufacturer City | CUYAHOGA FALLS OH 44223 |
| Manufacturer Country | US |
| Manufacturer Postal | 44223 |
| Manufacturer Phone | 3309168800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5 X5 NON-LATEX DAM |
| Product Code | EIE |
| Date Received | 2015-07-10 |
| Model Number | NA |
| Catalog Number | H09930 |
| Lot Number | 203V |
| ID Number | NA |
| Device Expiration Date | 2019-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLTENE/WHALEDENT INC. |
| Manufacturer Address | CUYAHOGA FALLS OH 44223 US 44223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-10 |