MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-04-16 for MED HOWMEDICA BONE PLUG 1PK 6215-5-011 manufactured by Howmedica, Inc..
[17639938]
Summary of evaluation: the evaluation results indicated that the event was attributed to a less than optimum design of the inner package envelope. Corrective action has been implemented to preclude the likelihood of similar events.
Patient Sequence No: 1, Text Type: N, H10
[18168626]
The inner and outer packaging was adhered together upon opening. There was no adverse consequence for the pt or delay in surgery or anesthesia time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2219689-1997-00198 |
| MDR Report Key | 86232 |
| Report Source | 07 |
| Date Received | 1997-04-16 |
| Date of Report | 1997-04-15 |
| Date of Event | 1997-03-12 |
| Date Facility Aware | 1997-03-12 |
| Report Date | 1997-04-15 |
| Date Mfgr Received | 1997-03-12 |
| Date Added to Maude | 1997-04-25 |
| 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 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MED HOWMEDICA BONE PLUG 1PK |
| Generic Name | IMPLANT |
| Product Code | MBS |
| Date Received | 1997-04-16 |
| Model Number | NA |
| Catalog Number | 6215-5-011 |
| Lot Number | UUMLA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 85425 |
| Manufacturer | HOWMEDICA, INC. |
| Manufacturer Address | 359 VETERANS BLVD. RUTHERFORD NJ 070702584 US |
| Baseline Brand Name | ARTISAN BONE PLUG |
| Baseline Generic Name | BONE PLUG |
| Baseline Model No | NA |
| Baseline Catalog No | 6215-5-011 |
| Baseline ID | NA |
| Baseline Device Family | BONE PLUG |
| Baseline Shelf Life Contained | N |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K951860 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-04-16 |