MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2010-03-15 for HENRY SCHEIN NON STERILE COTTON ROLLS #2 102-5455 manufactured by A.r. Medicom, Inc..
[1483694]
Since (b)(6) 2009, the doctor alleges they had six different pts experience various levels of what looks like a chemical burn caused by the cotton rolls. Some of the pts had to be treated with antibiotics as a result. The pt was treated on (b)(6) 2009, doctor placed cotton roll in lower right quadrant in front of her teeth behind lip, pt felt burning but did not mention it to the doctor. The pt came back two days later and explained there was burning on other side of mouth. Pt returned on (b)(6) 2010 and given a prescription of antibiotics by the doctor. There was peeling and tight, scarring tissue.
Patient Sequence No: 1, Text Type: D, B5
[8486821]
Method eval: biocompatibility tests (retesting). Results not yet available. (initial testing results are available but the testing results conducted on complaint samples are still to come). Conclusion: this type of incident was reported exclusively by one complainant, dr (b)(6). Based on the volume of these products that have been in use on the market since nov 2008, the acceptable biocompatibility tests results obtained on one of the first batches of products mfg as described, and the fact that no other incident of this nature was ever brought to our attention, we have no clear evidence that the injuries reported by dr (b)(6) are directly related to the cotton rolls. We manufacture and distribute this product on other markets (b)(4), and no other similar complaint was filed for this product or for any other brands of the similar cotton rolls that we manufacture.
Patient Sequence No: 1, Text Type: N, H10
[6080560]
Since (b)(6) 2009, the doctor alleges they had six different pts experience various levels of what looks like a chemical burn caused by the cotton rolls. Some of the pts had to be treated with antibiotics as a result. The pt a (b)(6) female was seen on (b)(6) 2010. Doctor was working on the pt's very back right of mouth when the pt complained of burning. The doctor claims it looked like a chemical burn and discoloration; lip was burning. The doctor also alleges the cotton rolls instantly burned pt, not even 30 seconds in mouth. Mouth was rinsed with water. Pt was seen next day, the skin was coming off and pt had a mild burn.
Patient Sequence No: 2, Text Type: D, B5
[14233150]
Method eval: biocompatibility tests (retesting). Results not yet available. (initial testing results conducted on complaint samples are still to come). Conclusion: this type of incident was reported exclusively by one complainant, dr (b)(6). Based on the volume of these products that have been in use on the market since nov 2008, the acceptable biocompatibility tests results obtained on one of the first batches of products mfg as described, the fact that no other incident of this nature was ever brought to our attention, we have no clear evidence that the injuries reported by dr (b)(6) are directly related to the cotton rolls. We mfr and distribute this product on other markets (b)(4) and no other similar complaint was filed for this product or for any other brands of the similar cotton rolls that we manufacture.
Patient Sequence No: 2, Text Type: N, H10
[6355874]
Since (b)(6) 2009, the doctor alleges they had six different pts experience various levels of what looks like a chemical burn caused by the cotton rolls. Some of the pts had to be treated with antibiotics as a result. The patient a (b)(6) female was seen on (b)(6) 2009. The pt's mouth was numb when the doctor worked on the lower right of mouth. The doctor alleges the front part of mouth was frozen; therefore, the pt did not feel the burning. One month later, the pt came back to the office and complained of a burn and scar. Pt went to physician for antibiotics as the infection had set in. Doctor claims the burn took one month to heal and pt had scarring.
Patient Sequence No: 3, Text Type: D, B5
[14087130]
Method eval: biocompatibility tests (retesting). Results not yet available. (initial testing results conducted on complaint samples are still to come). Conclusion: this type of incident was reported exclusively by one complainant, dr (b)(6). Based on the volume of these products that have been in use on the market since nov 2008, the acceptable biocompatibility tests results obtained on one of the first batches of products mfg as described, the fact that no other incident of this nature was ever brought to our attention, we have no clear evidence that the injuries reported by dr (b)(6) are directly related to the cotton rolls. We mfr and distribute this product on other markets (b)(4) and no other similar complaint was filed for this product or for any other brands of the similar cotton rolls that we manufacture.
Patient Sequence No: 3, Text Type: N, H10
[6327628]
Since (b)(6) 2009, the doctor alleges they had six different pts experience various levels of what looks like a chemical burn caused by the cotton rolls. Some of the pts had to be treated with antibiotics as a result. The pt a (b)(6) male seen on (b)(6) 2010. The doctor claims the pt has a burn on the inside of lip exactly the same shape of the cotton roll. The pt instantly complained when placed in the mouth that the cotton roll burned. Pt called the doctor back a few times alleging that it feels like he has a paper stuck to his lip and it feels like a chemical burn without the pain.
Patient Sequence No: 4, Text Type: D, B5
[13519984]
Method eval: biocompatibility tests (retesting). Results not yet available. (initial testing results conducted on complaint samples are still to come). Conclusion: this type of incident was reported exclusively by one complainant, dr (b)(6). Based on the volume of these products that have been in use on the market since nov 2008, the acceptable biocompatibility tests results obtained on one of the first batches of products mfg as described, the fact that no other incident of this nature was ever brought to our attention, we have no clear evidence that the injuries reported by dr (b)(6) are directly related to the cotton rolls. We mfr and distribute this product on other markets (b)(4) and no other similar complaint was filed for this product or for any other brands of the similar cotton rolls that we manufacture.
Patient Sequence No: 4, Text Type: N, H10
[6080665]
Since (b)(6) 2009, the doctor alleges they had six different pts experience various levels of what looks like a chemical burn caused by the cotton rolls. Some of the pts had to be treated with antibiotics as a result. The pt a (b)(6) female was seen on (b)(6) 2010. The doctor had performed some fillings in the front of the mouth. During a f/u visit, eight days later, the pt told the doctor of a burn in the front of mouth like a large canker sore.
Patient Sequence No: 5, Text Type: D, B5
[13845811]
Method eval: biocompatibility tests (retesting). Results not yet available. (initial testing results conducted on complaint samples are still to come). Conclusion: this type of incident was reported exclusively by one complainant, dr (b)(6). Based on the volume of these products that have been in use on the market since nov 2008, the acceptable biocompatibility tests results obtained on one of the first batches of products mfg as described, the fact that no other incident of this nature was ever brought to our attention, we have no clear evidence that the injuries reported by dr (b)(6) are directly related to the cotton rolls. We mfr and distribute this product on other markets (b)(4) and no other similar complaint was filed for this product or for any other brands of the similar cotton rolls that we manufacture.
Patient Sequence No: 5, Text Type: N, H10
[6076753]
Since (b)(6) 2009, the doctor alleges they had six different pts experience various levels of what looks like a chemical burn caused by the cotton rolls. Some of the pts had to be treated with antibiotics as a result. The pt a (b)(6) female seen on (b)(6) 2009. The pt was having a bridge pre on 3-6 area, a cotton roll was placed in the upper area of mouth. The next day, the pt ended up with a huge canker sore which took ten days to heal.
Patient Sequence No: 6, Text Type: D, B5
[13866082]
Method eval: biocompatibility tests (retesting). Results not yet available. (initial testing results conducted on complaint samples are still to come). Conclusion: this type of incident was reported exclusively by one complainant, dr (b)(6). Based on the volume of these products that have been in use on the market since nov 2008, the acceptable biocompatibility tests results obtained on one of the first batches of products mfg as described, the fact that no other incident of this nature was ever brought to our attention, we have no clear evidence that the injuries reported by dr (b)(6) are directly related to the cotton rolls. We mfr and distribute this product on other markets (b)(4) and no other similar complaint was filed for this product or for any other brands of the similar cotton rolls that we manufacture.
Patient Sequence No: 6, Text Type: N, H10
| Report Number | 9680179-2010-00001 |
| MDR Report Key | 1632532 |
| Report Source | 05,06,08 |
| Date Received | 2010-03-15 |
| Date of Report | 2010-02-09 |
| Date of Event | 2009-09-15 |
| Date Facility Aware | 2010-02-09 |
| Report Date | 2010-03-02 |
| Date Reported to FDA | 2010-03-05 |
| Date Reported to Mfgr | 2010-03-02 |
| Date Mfgr Received | 2010-02-16 |
| Device Manufacturer Date | 2008-07-01 |
| Date Added to Maude | 2011-01-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 1200 55TH AVE. STE 200 |
| Manufacturer City | MONTREAL, QUEBEC H8T 3J8 |
| Manufacturer Country | CA |
| Manufacturer Postal | H8T 3J8 |
| Manufacturer G1 | A.R. MEDICOM, INC.(SHANGHAI) LTD |
| Manufacturer Street | 290-302 XIANGCHE RD SONGJIANG DISTRICT |
| Manufacturer City | SHANGHAI 201611 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 201611 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HENRY SCHEIN NON STERILE COTTON ROLLS #2 |
| Generic Name | NON STERILE COTTON ROLLS #2 |
| Product Code | EFN |
| Date Received | 2010-03-15 |
| Returned To Mfg | 2010-03-01 |
| Catalog Number | 102-5455 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A.R. MEDICOM, INC. |
| Manufacturer Address | SHANGHAI CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-15 |
| 2 | 0 | 1. Other | 2010-03-15 |
| 3 | 0 | 1. Other | 2010-03-15 |
| 4 | 0 | 2010-03-15 | |
| 5 | 0 | 1. Other | 2010-03-15 |
| 6 | 0 | 1. Other | 2010-03-15 |