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 2003-08-13 for DELTA-SPLINT SYNTH RL 4"X15FT 51143 manufactured by Depuy-north Brunswick, Casting Products Division.
[321529]
Patient suffered from maceration 3 days after application of the delta splint tonguette. The user noticed that the humidity used to activate the longuette still was not evaporated on the 3rd day, so that the longuette still was very wet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2003-00530 |
| MDR Report Key | 477552 |
| Report Source | 01,05,08 |
| Date Received | 2003-08-13 |
| Date of Report | 2003-07-18 |
| Date of Event | 2003-07-18 |
| Date Facility Aware | 2003-07-18 |
| Report Date | 2003-07-18 |
| Date Mfgr Received | 2003-07-18 |
| Date Added to Maude | 2003-08-15 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | DELTA-SPLINT SYNTH RL 4"X15FT |
| Generic Name | CASTING PRODUCTS |
| Product Code | FYH |
| Date Received | 2003-08-13 |
| Model Number | NA |
| Catalog Number | 51143 |
| Lot Number | 1141 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 466358 |
| Manufacturer | DEPUY-NORTH BRUNSWICK, CASTING PRODUCTS DIVISION |
| Manufacturer Address | 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 | 2003-08-13 |