MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-02 for HENRY SCHEIN 102-5455 manufactured by A.r. Medicom Inc. (shanghai) Co.,ltd..
[99330096]
On 14-jul-2015, a medwatch was reported to the fda by (b)(4), and refers to amd medicom sterile (b)(4) cotton rolls economic non sterile 102-5455 in which the following was reported: "two female patients had experienced blistering and redness immediately after a routine procedure. As a result both female patients were prescribed kenalog cream to help treat the blistering and redness. Patient 1: female, (b)(6), patient 2: female, age not disclosed" the (b)(4) complaint was received by a. R. Medicom (b)(4) on 23-jun-2015 and has been logged as product quality complaint (b)(4) with the following additional information being provided: "one staff member, a female in her 50's touched her lip and turned bright red. The doctor advised that other unknown amount of patients had similar reactions, not sure of how many/sex/ ages. No further treatment required. A staff person had to have kenalog administer to blisters as was the same with one other patient, was administered kenalog". A request for an investigation was immediately made to the manufacturing site (b)(4). At the time of reception of the quality complaint, an evaluation was performed by amd medicom and it was determined that additional information was required in order to complete the investigation. Therefore, a questionnaire was forwarded to the complainant on 29-jun-2015 and a response obtained on 08-jul-2015 as detailed below: - have you changed your ordering recently (different cotton roll type)? Have always used this type of cotton roll. - what and how do you store your cotton rolls (in a case, box, drawer? Typically store in the box they come in or a drawer. - can you describe more the symptoms? As the cotton roll touched the staff members lip, it turned red and also had blisters develop. - how many patients had this reaction? Had quite a few patients with the same symptoms however only two needed prescription kenalog cream. Not specific about other person (age or sex). - sex of each patient: one staff member is a female, other patient did not specify. - was it the first time the patient used this lot of cotton rolls? Yes, the first time for this lot. - was it the first time the patient used this type of cotton rolls? Not the first time they used this type of cotton roll. - upon using the cotton rolls, after what duration of time did the symptoms appear (e. G. 5, 10 minutes)? The symptoms were immediate about five minutes. - once the cotton roll was removed, how long did the symptoms persist? Customer did not indicate how long after the symptoms persisted. - did the symptoms subside or disappear due to any treatment (medication? )? Both a female staff member and a patient needed to get prescription kenalog cream. - was the patient hospitalized? No one needed to be hospitalized. - did the patient have a history of allergy? Neither the staff member or patient have a history or allergy. Even though requests were made to the complainant for the return of the item code 102-5455 lot 18636, at that time, no product was returned by the complainant or samples provided. Therefore, retained samples received from the manufacturing site were sent to a third party contract laboratory 05-aug-2015 in order to perform a cytotoxicity test. On 14-aug-2015, the final report was received from the third party external contract laboratory which indicated that the cotton rolls retained samples pass the cytotoxicity test with a score of 0. Based on the review of the above responses obtained from the complainant, the cytotoxicity testing and after further investigation, a second set of questions were submitted for a response on 17-aug-2015: - was this lot stored in the original box or drawer? Typically they store these in the box they come in, some are in drawers. - did they still have a stock of this specific lot? If yes, did they still use it? We have sent a second notification to our customer to return the affected product; however we have not yet received it as of today. - could you please describe their routine procedure? They were not specific in providing the routine procedure. Review of the dhr indicated that lot 18636 was manufactured in compliance with current procedures and internal specifications. No deviations were noted during the manufacturing process. It should be mentioned that as part of the manufacturing process, the cotton rolls were pretreated by gamma prior to shipment. A review of all complaints received by amd medicom over the last two (2) years has indicated that there was no other complaint received with respect to this particular product and the nature of the complaint. Based on the above investigation and the conclusive cytotoxicity data (that the cotton rolls from lot 18636 resulted in a score 0), it can be considered that the reaction is not linked to the product itself but most probably related to the manner the cotton rolls were stored and/or manipulated while treating the patients. Note: the medwatch should have completed and submitted to fda on aug, 2015. Due to miscommunication between (b)(4) and amd medicom, the final conclusion to the medwatch was not submitted as required. It was understood by amd medicom at that time that the conclusion of the medwatch was to be sent by (b)(4). Corrective actions have been implemented internally to avoid any future misunderstanding and prompt completion of any medwatch.
Patient Sequence No: 1, Text Type: N, H10
[99330097]
"two female patients had experienced blistering and redness immediately after a routine procedure. As a result both female patients were prescribed kenalog cream to help treat the blistering and redness. Patient 1: female, (b)(6), patient 2: female, age not disclosed"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611959-2015-00001 |
| MDR Report Key | 7239338 |
| Date Received | 2018-02-02 |
| Date of Report | 2017-11-06 |
| Date of Event | 2015-06-17 |
| Date Facility Aware | 2015-06-23 |
| Report Date | 2015-07-14 |
| Date Reported to FDA | 2015-07-14 |
| Date Reported to Mfgr | 2015-07-16 |
| Date Mfgr Received | 2015-06-23 |
| Device Manufacturer Date | 2014-11-25 |
| Date Added to Maude | 2018-02-02 |
| 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 Contact | MS. DOMINIQUE ABECASSIS |
| Manufacturer Street | 1200 55TH AVENUE |
| Manufacturer City | LACHINE (MONTREAL), QUEBEC H8T 3J8 |
| Manufacturer Country | CA |
| Manufacturer Postal | H8T 3J8 |
| Manufacturer G1 | A.R. MEDICOM INC. (SHANGHAI) CO.LTD. |
| Manufacturer Street | 290-302 XIANGCHE ROAD SONJANG DISTRICT |
| Manufacturer City | SHANGHAI, CHINA |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HENRY SCHEIN |
| Generic Name | COTTON ROLLS NON-STERILE # 2 MEDIUM |
| Product Code | EFN |
| Date Received | 2018-02-02 |
| Returned To Mfg | 2015-10-20 |
| Catalog Number | 102-5455 |
| Lot Number | 18636 |
| Operator | DENTIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | A.R. MEDICOM INC. (SHANGHAI) CO.,LTD. |
| Manufacturer Address | 290-302 XIANGCHE ROAD SONGJANG DISTRICT, SHANGHAI, CHINA 201611 CH 201611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-02 |