MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-04-12 for SHARPOINT G701-500 manufactured by Surgical Specialties Puerto Rico Inc. Dba Angiotech.
[3277785]
Customer states that the pt sustained a fall while wearing product. Product broke in to multiple fragments when the pt fell, causing damage to the orbital area of the pt's face. Ref pr complaint #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10664938]
The actual product involved with the incident reported was discarded. Method: the device was discarded, no product eval can be performed. Results/conclusions: the device was discarded. No product eval can be performed. Without the lot code information being provided, relevant portions of the device history record could not be reviewed for corresponding issues identified during the manufacturing processes or at final inspection. Due to lot number was not reported, a warehouse review for available inventory of the same lot was not able to be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008845715-2013-00002 |
| MDR Report Key | 3063091 |
| Report Source | 08 |
| Date Received | 2013-04-12 |
| Date of Report | 2013-04-11 |
| Date of Event | 2013-01-12 |
| Date Mfgr Received | 2013-04-08 |
| Date Added to Maude | 2013-04-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARCIA CARO, MANAGER |
| Manufacturer Street | ROAD 459 KM 0.6 MONTANA INDUSTRIAL PARK |
| Manufacturer City | AGUADILLA PR 00603 |
| Manufacturer Country | US |
| Manufacturer Postal | 00603 |
| Manufacturer Phone | 7876581800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHARPOINT |
| Generic Name | EYE GARTER, CLEAR UNIVERSAL |
| Product Code | HOY |
| Date Received | 2013-04-12 |
| Model Number | G701-500 |
| Catalog Number | G701-500 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGICAL SPECIALTIES PUERTO RICO INC. DBA ANGIOTECH |
| Manufacturer Address | AGUADILLA PR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-04-12 |