MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor report with the FDA on 2016-04-01 for FACE MASK HEAD STRAP 8150 manufactured by King Systems.
[41675101]
The face mask head strap is manufactured from (b)(4) and does not contain any natural rubber latex or powder.
Patient Sequence No: 1, Text Type: N, H10
[41675102]
Patient reported a skin reaction at the back of her head and is not certain of what caused it, but it is in the area where she was contacted by face mask head strap. The patient reports that she will undergo allergy testing in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824226-2016-00002 |
| MDR Report Key | 5541861 |
| Report Source | CONSUMER,DISTRIBUTOR |
| Date Received | 2016-04-01 |
| Date of Report | 2016-03-31 |
| Date of Event | 2016-03-18 |
| Date Mfgr Received | 2016-03-21 |
| Device Manufacturer Date | 2016-01-29 |
| Date Added to Maude | 2016-04-01 |
| 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 | MR. WAYNE NETHERCUTT |
| Manufacturer Street | 15011 HERRIMAN BLVD. |
| Manufacturer City | NOBLESVILLE IN 46060 |
| Manufacturer Country | US |
| Manufacturer Postal | 46060 |
| Manufacturer Phone | 3177763175 |
| Manufacturer G1 | KING SYSTEMS |
| Manufacturer Street | 15011 HERRIMAN BLVD. |
| Manufacturer City | NOBLESVILLE IN 46060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FACE MASK HEAD STRAP |
| Generic Name | STRAP, HEAD, GAS MASK |
| Product Code | BTK |
| Date Received | 2016-04-01 |
| Model Number | 8150 |
| Catalog Number | 8150 |
| Lot Number | 1865348 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KING SYSTEMS |
| Manufacturer Address | 15011 HERRIMAN BLVD. NOBLESVILLE IN 46060 US 46060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-01 |