MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-04-23 for HS-ETCHGEL BULKPACK 60 GRAM REFILL, 46 ML 1026893 manufactured by Septodont, Inc..
[106213861]
Manufacturer's preliminary analysis: a review of the complaint records indicate this is the only complaint received for lot number h010535a to-date; this is the second incident of similar nature received by the company in the past three years. The manufacturer's device analysis results: based on examination of the photographs provided, there is no indication of any failure in the syringe (no signs of cracks or breakage can be identified). Records from the incoming inspection of the syringe component associated with the reported lot number also indicate there were no instance of broken syringes from the inspection. As no quality defect could be identified from the above-described investigation, circumstances that may have contributed to the reported incident were reviewed. The instructions for use (ifu) for this device has clear written and illustrated instructions on how to refill 3 cc delivery syringes, as well as warning symbols and cautionary statements for safe and correct use of the product. The incident narrative, however, suggests the refill instructions were not fully followed by the nurse involved, as she had to "put the bulk syringe to her chest. " and "the nurse involved wore gloves, but not protective eye wear. " final comments from the manufacturer: in conclusion, based on the investigation and review of the incident narrative described above, the cause of the reported incident was most probable due to non-observance to the ifu; there was no confirmed quality defect associated with the reported device. For the safe use of henry schein etch syringe 60g refill, it is strongly recommended to observe all of the information presented in the instructions for use (ifu) document prior to using the product.
Patient Sequence No: 1, Text Type: N, H10
[106213862]
(b)(4). This spontaneous case was received in (b)(6) from a dentist via (b)(4). Initial information was received by (b)(4) on 29-jan-2018 and forwarded to septodont on 30-jan-2018. A (b)(6) female user, a nurse of the dental office, who wore gloves but no protective eye wear, manipulated on (b)(6) 2018 the device hs-? Tzgel jumbo refill, etchgel jumbo 60g/ hs-etchgel bulkpack 60 gram refill, 46 ml (etchant gel 40 %, batch # h010535a, expiration date: 2018-04). The syringe burst during filling to an empty syringe and the user got the etching gel into the eye. The nurse immediately rinsed the eye with a large amount of water and consulted in a hospital. The nurse's outcome, following consultation at hospital, was not reported. Follow-up 1 information (accident report from the insurance institution) and medical specialist statement were received on 01-mar-2018 from local distributor in (b)(6); translation to english was completed on 09-mar-2018. Further details of the dental office staff involved in the incident clarified: job title - dental treatment assistant, (b)(6). Further information concerning the incident provided on the translated accident report form are summarized below: date and time of incident: (b)(6) 2018 at 07:15 am. Location of incident: in the laboratory. Circumstances of incident: kind of work on date of incident: dental assistance. What did the person, having an accident, do on that moment: arrangement for activities during ordination. Which kind of object was involved in the activity? Etch gel 40% 60g syringe lot h010535a. What was different to normal activity? Refill-injection syringe broke. How was the person involved in the accident injured? Phosphor-solution splattered into the left eye. Which object was involved? Etch gel 40% 60g syringe lot h010535a. Description of the accident: during refilling of the etch gel the syringe broke and the phosphorus solution splattered into the left eye. The dentist was at place in the ordination, but not directly at place of accident, meaning not being a direct witness, since he was not in the same room. Description of the accident by: person having the accident. Witness: no witness. Information on kind of accident: chemical burn, etching. Marital status: unmarried; children: yes. Has the work been stopped? Immediately. Work was stopped on (b)(6) 2018. Emergency organisation involved? No. Accident investigation by police? No. Accident investigation by working-inspection? No. Treatment in hospital? Outpatient since (b)(6) 2018. Name of hospital: [hospital name redacted] ambulance for eye treatment. Medical treatment outside of hospital: no. Translation of the medical specialist statement from the ophthalmology ambulance: visit date: (b)(6) 2018. Diagnosis: chemical burn (etching) of the cornea and conjunctiva. Case history: patient came in on (b)(6) 2018, because phosphorous liquid splattered into her left eye. Investigation details: description: left eye with cornea spots, follicle, chemosis of the conjunctiva. Result: treatment with floxal [ofloxacin], 5x daily, ascorbic acid, 5x daily, prednifluid [prednisolone], 5x daily, vitapos [retinol palmitate (equivalent to vitamin a 250 iu/g)] 3x daily and if needed mexalen [acetaminophen] or ibuprofen. Ongoing regular control in the ambulance is intended. Follow-up 2 received on 09-mar-2018 from the local distributor after follow-up with the involved dental assistant: the nurse is further under medical treatment because her eyesight is still affected. She must continue to take her medication every day and cannot work the whole, only a few hours. Since the refilling into the small syringe required great force, the nurse put the bulk syringe to her chest. With this strong pressure, the large syringe burst at the front of the tip and get in the left eye of the nurse. Unfortunately, during the refilling the nurse wore no protective eye wear. No more information available. Follow-up 3 received on 16-apr-2018 from quality department: this is the only complaint received for reported batch # h010535a to-date; and this is the second incident of similar nature received by the company for the past 3 years. Based on examination of the photographs provided, review of the records from the incoming inspection of the syringe component associated with the reported lot number, no quality defect could be identified. The incident narrative suggests the refill instructions were not fully followed by the nurse involved, as she had to "put the bulk syringe to her chest. " and "the nurse involved wore gloves, but not protective eye wear. " the cause of the reported incident was most probable due to non-observance to the ifu; there was no confirmed quality defect associated with the reported device. Causality assessment on 01-mar-18 on initial information received on 29-jan-2018. Re-evaluated on 09-mar-2018 on additional information received on 01-mar-2018. Re-evaluated on 17-apr-18 on information received from the quality department on 16-apr-2018. Seriousness: serious (persistent or significant disability / incapacity; required intervention to prevent permanent impairment/damage (devices)). Listedness/expectedness: chemical burns of eye: unexpected eu, us; conjunctival oedema: unexpected eu, us; conjunctival follicles: unexpected eu, us; eye burns: unexpected eu, us ; product physical issue: unexpected eu, us. Exposure via eye contact: unexpected eu, us. Occupational exposure to product: unexpected eu, us. Causality: latency - suggestive. Recognized association - no. Analysis - this case describes an accidental exposure with etchant gel 40% following the breakage of the syringe. It is not known if the conditions of use of the product were followed, if it was placed at room temperature prior to use, or if the product had already been used, the syringe poorly recapped and the product could have dried. The results of analysis showed that no quality defect and no device breakage could be identified. The reported "syringe burst during filling to the empty syringe" refers to the expulsion of the etch gel from the syringe probably due to excessive pressure exerted on the syringe. The causal relationship between product physical issue and the product is considered as unlikely. In addition, no safety glasses were used by the practioner. Therefore the accidental exposure has a significant impact at the time of accidental eyes exposure and the user experienced chemical burn (etching) of the cornea and conjunctiva (left eye with cornea spots, follicle, chemosis of the conjunctiva). The causal relationship between the product and the events exposure via eye contact, chemical burns of eye, conjunctival oedema, conjunctival follicles, eye burns and occupational exposure to product as probable in context of non-compliance with safety recommendations (no worn glasses) and a bad product use (excessive pressure), as the product contains phosphoric acid (which is known to be at risk of burning eyes and, so, requires special precautions of use). Dechallenge - na. Rechallenge - na. Concluded causality who: unlikely for product physical issue; not assessable for occupational exposure to product due to the nature of event; probable for exposure via eye contact, chemical burns of eye, conjunctival oedema, conjunctival follicles, and eye burns in context of non-compliance with safety recommendations (no glasses) and a bad product use (excessive pressure). Follow-up received on 16-apr-2018: events "occupational exposure to product", "chemosis", "conjunctival follicles" and "corneal burn" were added. After receiving quality investigation results (which concluded that there was no confirmed product associated quality defect) company causality was changed from not assessable to unlikely for product physical issue (as it was suggested that the incident was most probably due to the non-observance to the product instruction of use) and was not changed from previous assessment for other events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001721729-2018-00006 |
| MDR Report Key | 7451738 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-04-23 |
| Date of Report | 2018-04-23 |
| Date of Event | 2018-01-25 |
| Date Mfgr Received | 2018-03-01 |
| Date Added to Maude | 2018-04-23 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LAWRENCE KASS |
| Manufacturer Street | 416 S TAYLOR AVE. |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal | 80027 |
| Manufacturer Phone | 3036657535 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HS-ETCHGEL BULKPACK 60 GRAM REFILL, 46 ML |
| Generic Name | ETCHANT 40% |
| Product Code | KLE |
| Date Received | 2018-04-23 |
| Model Number | BULKPACK 60 GRAM REFILL, 46 ML |
| Catalog Number | 1026893 |
| Lot Number | H010535AA |
| Device Expiration Date | 2018-04-30 |
| Operator | DENTAL ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEPTODONT, INC. |
| Manufacturer Address | 416 S TAYLOR AVE. LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-04-23 |