MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2003-10-22 for DELTA-SPLINT SYNTH RL 4" X 15FT 51143 manufactured by Depuy Ortho Tech- North Brunswick J&j Co..
[329938]
After 5 days of use it started to stink. The pt had macerations and blisters on skin. When the splint was removed there were spots on the splint and the pt's side.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2003-00709 |
| MDR Report Key | 490745 |
| Report Source | 01,05,08 |
| Date Received | 2003-10-22 |
| Date of Report | 2003-09-25 |
| Date Facility Aware | 2003-09-25 |
| Report Date | 2003-09-25 |
| Date Mfgr Received | 2003-09-25 |
| Device Manufacturer Date | 2003-04-01 |
| Date Added to Maude | 2003-10-24 |
| 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 | DEPUY ORTH TECH- NORTH BRUNSWICK J&J CO. |
| Manufacturer Street | ROUTE #1 AARON RD |
| 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 | DELTA-SPLINT SYNTH RL 4" X 15FT |
| Generic Name | SOFT GOODS |
| Product Code | FYH |
| Date Received | 2003-10-22 |
| Model Number | NA |
| Catalog Number | 51143 |
| Lot Number | 3106 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 479472 |
| Manufacturer | DEPUY ORTHO TECH- NORTH BRUNSWICK J&J CO. |
| Manufacturer Address | ROUTE #1 AARON RD 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 | 2003-10-22 |