MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07,08 report with the FDA on 2014-10-21 for 3610LF-8 manufactured by Bliss Health Products Co., Ltd..
[5042178]
Claimant states that she was walking on the sidewalk using her crutches when one of the crutches fell apart at the hand grip causing her to fall. She alleges the recently inserted pins in four small toes (left foot) were bent. She anticipates having the pins repaired in (b)(6) 2015 when the weather permits. She stated the crutches were purchased at a pharmacy the day before the incident wrapped in plastic. Her surgeon fitted the crutches prior to her use. No medical substantiation has been received.
Patient Sequence No: 1, Text Type: D, B5
[12546565]
The claimant returned the product to a and m pharmacy and surgical supplies following the alleged incident. On (b)(6) 2014 a and e pharmacy (dapesh) stated the handgrip bolt and wing nut were not returned and they needed authorization from kinray (pharmacy supplier) to return the crutches to gf health products, inc. For evaluation. Today, 10/21/2014, the pharmacy stated the crutches were thrown away. Hang tag attached to crutches: safety guidelines - please read before use. Warning: wing nuts must be tight at all times. Warning: if components are damaged or missing, contact your distributor immediately.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2428983-2014-00002 |
| MDR Report Key | 4208933 |
| Report Source | 04,07,08 |
| Date Received | 2014-10-21 |
| Date of Report | 2014-10-21 |
| Date of Event | 2014-07-01 |
| Date Facility Aware | 2014-09-21 |
| Report Date | 2014-10-21 |
| Date Reported to FDA | 2014-10-21 |
| Date Reported to Mfgr | 2014-10-21 |
| Date Mfgr Received | 2014-10-21 |
| Date Added to Maude | 2014-10-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SYBIL CHEN |
| Manufacturer Street | NO. 96M ZHAOYI RD. |
| Manufacturer City | DONSHEN TOWN, ZHONGSHAN CITY 301067589 |
| Manufacturer Country | CH |
| Manufacturer Postal | 3010675897 |
| Manufacturer Phone | 6022577301 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ADULT CRUTCHES |
| Product Code | IPR |
| Date Received | 2014-10-21 |
| Model Number | 3610LF-8 |
| Lot Number | BMP217MO |
| ID Number | KINRAY 430660 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BLISS HEALTH PRODUCTS CO., LTD. |
| Manufacturer Address | NO. 96, ZHAOYI RD. DONGSHEN TOWN, ZHONGSHAN CITY 528414 CH 528414 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-10-21 |