MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2003-02-26 for J-SPLINT 6INX15LYRX20FT 7336 manufactured by Depuy-north Brunswick, Castings Products Division.
[316815]
While splinting an elbow; the patient complained it was too hot. The patient received second degree burns as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2003-00106 |
| MDR Report Key | 444861 |
| Report Source | 05,08 |
| Date Received | 2003-02-26 |
| Date of Report | 2003-02-26 |
| Date of Event | 2003-01-17 |
| Date Facility Aware | 2003-01-27 |
| Report Date | 2003-02-26 |
| Date Mfgr Received | 2003-01-27 |
| Date Added to Maude | 2003-02-27 |
| 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 | HANS KUSSEROW, MGR. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727416 |
| Manufacturer G1 | DEPUY-NORTH BRUNSWICK |
| Manufacturer Street | ROUTE #1 AARON ROAD |
| Manufacturer City | NORTH BRUNSWICK NJ 08902 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08902 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | J-SPLINT 6INX15LYRX20FT |
| Generic Name | CASTING PRODUCT |
| Product Code | FYH |
| Date Received | 2003-02-26 |
| Returned To Mfg | 2003-02-11 |
| Model Number | NA |
| Catalog Number | 7336 |
| Lot Number | 28290#17 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNK |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 433839 |
| Manufacturer | DEPUY-NORTH BRUNSWICK, CASTINGS PRODUCTS DIVISION |
| Manufacturer Address | ROUTE #1 AARON ROAD NORTH BRUNSWICK NJ 08902 US |
| Baseline Brand Name | J-SPLINT 6INX15LYRX20FT |
| Baseline Generic Name | SPLINT |
| Baseline Model No | NA |
| Baseline Catalog No | 7336 |
| Baseline ID | NA |
| Baseline Device Family | J-SPLINT |
| Baseline Shelf Life Contained | N |
| 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 | 2003-02-26 |