MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-12-13 for DELTA-LITE C-SPLINT 4 IN X 15 IN 6840 manufactured by Depuy-pureto Rico/a Division Of Depuy Orthopaedics.
[16293253]
Claims that the pt received 2nd degree burns from the product. The padding side was toward the skin. The pt is being treated with antibiotic lotion for the next 1-2 weeks. Pt complained of itching; upon removal of the splint; found the arm to be extremely red and swollen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2000-00314 |
| MDR Report Key | 308287 |
| Report Source | 06 |
| Date Received | 2000-12-13 |
| Date of Report | 2000-12-13 |
| Date of Event | 2000-11-13 |
| Date Facility Aware | 2000-11-14 |
| Report Date | 2000-12-13 |
| Date Mfgr Received | 2000-11-14 |
| Date Added to Maude | 2000-12-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | HANS KUSSEROW, MGR. |
| Manufacturer Street | 700 ORTHOPAEDIC DR |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 2193727416 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DELTA-LITE C-SPLINT 4 IN X 15 IN |
| Generic Name | CASTING |
| Product Code | FYH |
| Date Received | 2000-12-13 |
| Model Number | NA |
| Catalog Number | 6840 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 298274 |
| Manufacturer | DEPUY-PURETO RICO/A DIVISION OF DEPUY ORTHOPAEDICS |
| Manufacturer Address | ROUTE 183, KM, 19.7 LAS PIEDRAS PR 007712015 US |
| Baseline Brand Name | DELTA-LITE C-SPLINT 4IN X 15IN |
| Baseline Generic Name | CASTING SPLINT |
| Baseline Model No | NA |
| Baseline Catalog No | 6840 |
| Baseline ID | NA |
| Baseline Device Family | DELTA LITE C-SPLINT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-12-13 |