MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-23 for * HLM37159 manufactured by Graham Field Surical.
[111669]
Blood leakage at seam level of leg splint allowing blood to penetrate between the two layers of vinyl. Sewn seam allows leakage. 8-18-97 afternoon run for trauma case. Leg splint applied to a very bloody leg. Splint was cleaned per protocol and hung to dry. Several hrs later, on a second ambulance run the splint was dry and free of visible contaminate. This splint was applied to pt of 2nd run for an injured leg/ankle. No bleeding from this pt. However, upon arrival at the hosp, there was noted blood on the pts sheet and his pant leg was wet. He did have non weeping pimply like areas on his lower leg. Therefore, the pt was treated for possible blood borne contamination and is to follow-up with retesting and hepatitis b vaccinations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 125528 |
| MDR Report Key | 125528 |
| Date Received | 1997-08-23 |
| Date of Report | 1997-08-21 |
| Date of Event | 1997-08-08 |
| Date Facility Aware | 1997-08-08 |
| Report Date | 1997-08-21 |
| Date Reported to FDA | 1997-08-21 |
| Date Reported to Mfgr | 1997-08-21 |
| Date Added to Maude | 1997-10-14 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | * |
| Generic Name | FRACTURE KIT (LEG SPLINT) |
| Product Code | FZF |
| Date Received | 1997-08-23 |
| Model Number | HLM37159 |
| Catalog Number | NI |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 122876 |
| Manufacturer | GRAHAM FIELD SURICAL |
| Manufacturer Address | 400 RABRO DR. HAUPPAUGE NY 11788 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-08-23 |