MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2003-06-05 for EXTRA-FAST PLASTER(GL) 5INX5YD 7369 manufactured by Depuy-north Brunswick/castings Products Division.
[305339]
The plaster molding tech advises the mold has given a patient a 2nd degree burn. (the mold is made prior to facilitate the manufacture of a customized splint).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2003-00328 |
| MDR Report Key | 464176 |
| Report Source | 05,08 |
| Date Received | 2003-06-05 |
| Date of Report | 2003-05-06 |
| Date of Event | 2003-05-02 |
| Date Facility Aware | 2003-05-06 |
| Report Date | 2003-05-06 |
| Date Mfgr Received | 2003-05-06 |
| Date Added to Maude | 2003-06-09 |
| 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 | EXTRA-FAST PLASTER(GL) 5INX5YD |
| Generic Name | SPLINT; EXTREMITY |
| Product Code | FYH |
| Date Received | 2003-06-05 |
| Returned To Mfg | 2003-05-19 |
| Model Number | NA |
| Catalog Number | 7369 |
| Lot Number | 0173N002 |
| 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 | 453117 |
| Manufacturer | DEPUY-NORTH BRUNSWICK/CASTINGS PRODUCTS DIVISION |
| Manufacturer Address | ROUTE #1 AARON RD. NORTH BRUNSWICK NJ 08902 US |
| Baseline Brand Name | EXTRA-FAST PLASTER (GL) 5IN X 5YD |
| Baseline Generic Name | SPLINT |
| Baseline Model No | NA |
| Baseline Catalog No | 7369 |
| Baseline ID | NA |
| Baseline Device Family | EXTRA-FAST PLASTER |
| 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 | 2003-06-05 |