MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2015-04-21 for MCKESSON PUSH BUTTON ALUMINUM CRUTCH 14-905 manufactured by Jan Mai Industries Co Ltd.
[17585070]
The pt claims that her crutches needed to be adjusted. While trying to adjust the crutch, the pt severed her left ring finger (fatty part) behind her nail. She was treated at urgent care and released. Urgent care was unable to stitch her finger and they had to cauterize it. On (b)(6) 2015, the pt was contacted to obtain info. The pt explained that she couldn't get the crutch to adjust and that it was "sticking" badly. She had to use force to get it to move. The crutch cut off the flesh at the end of her finger and under her nail. This occurred saturday (b)(6) 2015. She went to get treatment and her wound was cauterized with silver nitrate. She had to get several shots, including tetanus, as well as several local anesthetics. The pt stated she still has the crutch if it is needed for investigation. Additional follow up was conducted with the pt on (b)(6) 2015 (to obtain info required for this report). The pt provided further clarification that the pad of her finger got caught in one of the pre-drilled holes used to adjust the height of the crutch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451040-2015-00002 |
| MDR Report Key | 4723712 |
| Report Source | 99 |
| Date Received | 2015-04-21 |
| Date of Report | 2015-03-25 |
| Date of Event | 2015-03-21 |
| Date Facility Aware | 2015-03-27 |
| Report Date | 2015-04-21 |
| Date Added to Maude | 2015-04-24 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1202 SOUTH ROUTE 31 |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal | 60050 |
| Manufacturer G1 | CYPRESS MEDICAL PRODUCTS LLC |
| Manufacturer Street | 1202 SOUTH ROUTE 31 |
| Manufacturer City | MCHENRY IL 60050 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60050 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCKESSON PUSH BUTTON ALUMINUM CRUTCH |
| Product Code | IPR |
| Date Received | 2015-04-21 |
| Catalog Number | 14-905 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JAN MAI INDUSTRIES CO LTD |
| Manufacturer Address | NO 181 CHU LIAO RD TA SU HSIANG, KAOHSIUNG COUNTY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-21 |