MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-06-11 for ENCORE * 00229 manufactured by Encore.
[15441710]
Add'l info rec'd from mfr 8/20/02: encore medical, l. P. Soft goods division was unable to contact the device operator (end user) to understand the event on the mdr report, but completed an investigation on the incident stated on medical device report number mw1025267, splint, extremity, noninflatable, external and has concluded that the incident should not be warranted as an mdr reportable-event, where there was no indication of a significant medical device adverse event or product problem. Encore's investigation concluded that there are two outsourcing suppliers for this product (knee immobilizer, item # 00229) and the product does meet all encore's specs and its functionality. Also, encore recently inquired this product and others from kimberly-clark soft goods line including their entire inventory that might have confused the end user on this possibility. Due to the fact that this incident does not constitute or should have not been considered as an mdr reportable-event, encore is requesting for the fda to remove the report from any fda documentation and/or medical device reporting website.
Patient Sequence No: 1, Text Type: D, B5
[17763304]
Rptr received an incorrect and inferior product in a box with the same catalog # as before, but the product is a different one. The co kept the same cat # but keeps putting a different and inferior product in that same box. This has been brought to their attention 4 times.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1025267 |
| MDR Report Key | 399117 |
| Date Received | 2002-06-11 |
| Date of Report | 2002-06-11 |
| Date of Event | 2002-04-01 |
| Date Added to Maude | 2002-06-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENCORE |
| Generic Name | KNEE IMMOBILIZER |
| Product Code | FYH |
| Date Received | 2002-06-11 |
| Model Number | * |
| Catalog Number | 00229 |
| Lot Number | ENC 303 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 388161 |
| Manufacturer | ENCORE |
| Manufacturer Address | 9800 METRIC BLVD AUSTIN TX 78758 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-06-11 |