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 2018-05-08 for ESP? M001201111 20-111 manufactured by Boston Scientific - Costa Rica (coyol).
[107699436]
Device evaluated by mfr: the complaint device was not returned by the customer; therefore, no product analysis could be performed. Hence, the complaint is not confirmed. The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107699437]
I was reported that when using the esp? Specialty gloves, the physician would have to use multiple pairs during a procedure due to tearing at the seams. No patient or provider complications were reported to be related to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-01291 |
| MDR Report Key | 7495633 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-08 |
| Date of Report | 2018-04-11 |
| Date Mfgr Received | 2018-04-11 |
| Date Added to Maude | 2018-05-08 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. SONALI ARANGIL |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Street | 2546 FIRST STREET PROPARK FREE ZONE |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| 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 | LZC |
| Date Received | 2018-05-08 |
| Model Number | M001201111 |
| Catalog Number | 20-111 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
| Manufacturer Address | 2546 FIRST STREET PROPARK FREE ZONE ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-08 |