MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-19 for NATUS BILIBAND EYE PROTECTOR 900642 , 900643 manufactured by Natus Medical Incorporated.
[55108884]
Customer stated that they have not recorded lot number of the product involved. Customer stated they have samples at the hospital and will be able to send them for investigation, but it is unknown if the samples are from the same lot involved in the incident reported. Natus medical currently waiting for product to be returned. When product is returned and evaluated, a follow-up report will be submitted. Pending product return.
Patient Sequence No: 1, Text Type: N, H10
[55108885]
This report is for incident #2 customer reported that they are aware of 5 incidents of patients experiencing skin rash. The rash was present on the entire area that would come into contact with the blue foam portion on the periorbital area of the infants. There was no rash under the white elastic securing portion. The skin became reddened. There were no blisters, open lesions, or drainage from the skin. Small raised bumps were noted on the skin where it was reddened. In two of the situations, phototherapy treatment had to be stopped early as the rash was so severe. There were no other interventions or treatments done as a result. No other abnormalities were noted. Customer is unsure of the part number of bilibands, but believes that #900642 and #900643 were involved. Customer was not able to provide natus with lot numbers for the product involved in these incidents.
Patient Sequence No: 1, Text Type: D, B5
[73354198]
In addition to reports of contact dermatitis, a strong acidic chemical smell was reported when opening the box of biliband products. The customer was able to provide (b)(4) products from the same lot in question for investigation. A non-scientific approach of smelling the clear plastic packages upon opening was used to check if a similar odor could be detected. No such smell was noted. It is possible that the odor had been slowly released through the non-airtight package during shipping and storage. Production documents were requested and subsequently provided by the supplier. The following documentation was provided: bill of materials for biliband, biocompatbility report, plain film sgs report, process flow of manufacturing biliband and veclor material safety data sheet. A review of the listed documentation did not reveal any suspicious source of an odor, and this investigation has been determined to be inconclusive. A search of similar complaints resulted in one similar complaint. In this case, the customer was unresponsive and the device was not returned for evaluation. Any report of similar complaints will be investigated by (b)(4) immediately. Please note that additional information, such as patient information, was requested from the customer with no response.
Patient Sequence No: 1, Text Type: N, H10
[73354199]
The customer reported that they are aware of 5 incidents of patients experiencing skin rash. The rash was present on the entire area that would come into contact with the blue foam portion on the periorbital area of the infants. There was no rash under the white elastic securing portion. The skin became reddened. There were no blisters, open lesions, or drainage from the skin. Small raised bumps were noted on the skin where it was reddened. In two of the situations, phototherapy treatment had to be stopped early as the rash was so severe. There were no other interventions or treatments done as a result. No other abnormalities were noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2016-00016 |
| MDR Report Key | 5961704 |
| Date Received | 2016-09-19 |
| Date of Report | 2016-08-23 |
| Date Mfgr Received | 2016-08-23 |
| Date Added to Maude | 2016-09-19 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JEFFREY MANTKOWSKI |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685143 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATUS BILIBAND EYE PROTECTOR |
| Generic Name | BILIBAND |
| Product Code | FOK |
| Date Received | 2016-09-19 |
| Model Number | 900642 , 900643 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-19 |