MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,08 report with the FDA on 2002-06-13 for DELTA-SPLINT SYNTH RL 4"X15FT 51143 manufactured by Depuy - North Brunswick.
[16824438]
The complaint is for irritation and skin burns. The doctor may have applied the splint improperly. He used the same technique he used for plaster splint-casting. He was unsure if he followed ifu directions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2002-00359 |
| MDR Report Key | 399478 |
| Report Source | 05,07,08 |
| Date Received | 2002-06-13 |
| Date Facility Aware | 2002-05-17 |
| Date Mfgr Received | 2002-05-17 |
| Date Added to Maude | 2002-06-18 |
| 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 DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727416 |
| 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-SPLINT SYNTH RL 4"X15FT |
| Generic Name | CASTING PRODUCT |
| Product Code | FYH |
| Date Received | 2002-06-13 |
| Returned To Mfg | 2002-05-23 |
| Model Number | NA |
| Catalog Number | 51143 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 388529 |
| Manufacturer | DEPUY - NORTH BRUNSWICK |
| Manufacturer Address | CASTING PRODUCTS DIVISION ROUTE #1, AARON ROAD NORTH BRUNSWICK NJ 08902 US |
| Baseline Brand Name | DELTA-SPLINT SYNTH RL 4"X15FT |
| Baseline Generic Name | CASTING PRODUCT |
| Baseline Model No | NA |
| Baseline Catalog No | 51143 |
| Baseline ID | NA |
| Baseline Device Family | DELTA SPLINT CASTING |
| Baseline Shelf Life Contained | * |
| 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 | 2002-06-13 |