MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-16 for ESP 37415 manufactured by Boston Scientific Corporation.
[127454821]
The event date was not reported; the first date of the month of the aware date was used.
Patient Sequence No: 1, Text Type: N, H10
[127454822]
It was reported that several pairs of size 8 esp specialty gloves had been opened and every pair had a hole in the wrist. There were no patient or physician injuries or issues reported to have occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2018-62846 |
| MDR Report Key | 8080117 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-16 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-25 |
| Device Manufacturer Date | 2017-08-10 |
| Date Added to Maude | 2018-11-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SONALI ARANGIL |
| Manufacturer Street | TWO SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 6515827403 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESP |
| Generic Name | GLOVE, PATIENT EXAMINATION, SPECIALTY |
| Product Code | IWP |
| Date Received | 2018-11-16 |
| Model Number | 37415 |
| Catalog Number | 37415 |
| Lot Number | 0020986742 |
| Device Expiration Date | 2019-02-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | TWO SCIMED PLACE MAPLE GROVE MN 55311 US 55311 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-16 |