MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-25 for HIGH-PULL HEADCAP 016-000 NA manufactured by Hood-gear Pacific, Inc..
[16987]
Female pt was prescribed and fitted with a "high-pull headcap" in late 12/94. During an appointment with dentist on 2/3/95, he observed abrasions on both of the pts' ears, purportedly caused by straps on the device. The device was removed by dentist. The pt subsequently contracted a stapylococcus infection, possible at the abrasion sites. The pt sought and received treatment from a physician and a dermatologist. At this time, pt's abrasions have healed. On 5/29/95, all high pull headgear with the same design as the product used by the pt in question which he had in inventory was quarantined for shipment back to the supplier. A new design which eliminates the suspected problem site on the headgear has been substituted for the original inventory and will be shipped wth all future orders.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2018192-1995-00001 |
| MDR Report Key | 21627 |
| Date Received | 1995-04-25 |
| Date of Report | 1995-03-29 |
| Date of Event | 1995-02-03 |
| Date Facility Aware | 1995-03-24 |
| Report Date | 1995-03-29 |
| Date Reported to FDA | 1995-03-29 |
| Date Reported to Mfgr | 1995-03-29 |
| Date Added to Maude | 1995-05-04 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH-PULL HEADCAP |
| Generic Name | ORTHODONTIC HEADGEAR |
| Product Code | DZB |
| Date Received | 1995-04-25 |
| Returned To Mfg | 1995-03-29 |
| Model Number | 016-000 |
| Catalog Number | NA |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Age | 8 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21669 |
| Manufacturer | HOOD-GEAR PACIFIC, INC. |
| Manufacturer Address | 5620 61ST ST NE STE A MARYVILLE WA 98270 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-04-25 |