MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-16 for RESOUND LS561-DRW MP 19396901 manufactured by Gn Resound A/s.
[33587966]
Review of device history file: the xmn dmr was reviewed. 1587114347; passed final test (b)(6) 2015; 1587114357; passed final test (b)(6) 2015. Both devices passed without comments no changes or abnormalities reported in dhr materials with skin contact have been review by our material specialist. All materials with skin contact has passed bio compliance testing prior to release. Review of production process: components used was reviewed in pr? St? Production: corresponding top housing item no. : 18525601, lot no: 22233438; corresponding bottom housing item no. : 18525701, lot no: 22193191; there have been no changes to materials or processes recorded. Review of returned devices: the devices was returned to (b)(4). There were no visual defects to be identified. Domes was not returned with the devices. There were no visual contamination from alternative sources like storage conditions, cleaning agents, lubricants, etc. That potentially could have led to an allergic reaction. Chemical testing returned devices: the hearing aids within ms0023693 seem to contain a mixture of silicone oil, triglyceride (probably from the skin) and probably wood rosin. A virgin housing (i. E. The reference) does not show the above. This indicates external contamination, but not from the end user case. Review of customer event: the customer reports an allergic reaction produced by 2 bte devices model ls961-drw. The allergic reaction appeared the next morning, after being wearing the devices for only 3 hours and 8 hours sleeping. The patient shows a soreness around her ear (but not inside the ear canal), her face, her shoulders, her arms, her back and part of her chest. She also shows a big swallowing on her right eye that barely allows her to open it. According to the corporate procedure 0271620 rev. B the following feedback was obtained: the end user didn't use any cleaning agent (the devices were new); she usually wears hearing aids but no history of allergy has been reported; it was an open fit with surefit domes (the domes were disposed before shipping the hearing aids back); the patient used the instruments for 3 hours; the patient is now under medical treatment with corticosteroid (not specified by the dispenser); no surgeries have been made to the patient's ear; the patient was not following any medical treatment and was not having any medicines when the allergy appeared; she is binaurally fitted and she has experienced symptoms in both ears, shoulders, and arms. The devices was returned to gnr spain on a credit note. It has through the investigation not been possible to obtain additional information from the dispensing audiologist to the event, or to if the patient recovered, or if an alternative solution was found. Final conclusion: the hearing aids seem to contain a mixture of silicone oil, triglyceride (probably from the skin) and probably wood rosin. A virgin housing (i. E. The reference) does not show the above. This indicates external contamination, but not from the end user case as none of the above identified materials are part of the bom or supportive substances used in the production line. From experience we also know that even though hearing aid and its associated accessories is designed and produced with material verified to be non-allergenic there is a small fraction of end users that are hyper sensitive to specific materials. In these cases the end user is often aware of their allergies and will ask for material properties of the supplied device prior to usage. If the event is new a dermatologist may be involved in understanding why the allergic reaction occurred and ask for supportive material data. If dermatitis does not resolve after the patient has discontinued wearing the hearing aid, referral to a dermatologist is recommended above is further supported by gnr document "safety related complaints - decision tree 0271620". Finally we cannot exclude the event can has been caused by decease not related to the hearing aid (stress response, etc. ). Reporting: based on the chemical analysis of the returned device, the device seems to be contaminated with a mixture of silicone oil, triglyceride and wood rosin. It is unclear where this contamination come from, but according to our investigation and review of material used in production, it is unlikely that the devices have received this contamination from internal sources as none of the detected chemicals are used in our production, packaging or handling processes. It is not possible to determine if the allergic reaction was caused by the contamination, or potentially hypersensitivity to the biocompatible plastic materials used in the hearing aid (a small portion of patients can show hypersensitivity to almost any material) or if the allergic reaction was caused by a decease not related to the hearing aid. However, as we cannot exclude that our device have contributed to the event and as the allergic reaction seems to have been of the more severe kind, we regard this as a serious injury and thus as a reportable event. Reporting must be made to the spanish national competent authorities as the event occurred in spain. As the model is sold in the us the mdr should also be filed by fda. No recall or corrective actions are necessary. The complaint database will be monitored in order to detect any substantial increase in the frequency for similar events. A copy of the report will furthermore be send to the notified body dqs to ensure their awareness of the event.
Patient Sequence No: 1, Text Type: N, H10
[33587967]
Allergic reaction reported by the dispenser: the customer reports an allergic reaction produced by 2 bte devices model ls961-drw. The allergic reaction appeared the next morning, after being wearing the devices for only 3 hours and 8 hours sleeping. The patient shows a soreness around her ear (but not inside the ear canal), her face, her shoulders, her arms, her back and part of her chest. She also shows a big swallowing on her right eye that barely allows her to open it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005650109-2015-00002 |
| MDR Report Key | 5301559 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-16 |
| Date of Report | 2015-12-04 |
| Date of Event | 2015-10-29 |
| Date Mfgr Received | 2015-10-29 |
| Device Manufacturer Date | 2015-09-18 |
| Date Added to Maude | 2015-12-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | AUDIOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARS HAGANDER |
| Manufacturer Street | LAUTRUPBJERG 7 |
| Manufacturer City | BALLERUP, 2750 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2750 |
| Manufacturer Phone | 5 45752100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESOUND |
| Generic Name | LINX2 |
| Product Code | OSM |
| Date Received | 2015-12-16 |
| Returned To Mfg | 2015-11-06 |
| Model Number | LS561-DRW MP |
| Catalog Number | 19396901 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GN RESOUND A/S |
| Manufacturer Address | LAUTRUPBJERG 7 BALLERUP, 2750 DA 2750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-16 |