MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-27 for SANI-SCOPE DISP ANOSCOPE 82420 manufactured by Coopersurgical, Inc..
[112934623]
Coopersurgical, inc is currently investigating the reported condition. Once the investigation is complete, a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[112934624]
"obturator tip has come apart inside of patients rectum and has to be removed by doctor causing great discomfort on more than one occasion and not just the lot number above. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00031 |
| MDR Report Key | 7648218 |
| Date Received | 2018-06-27 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-05-04 |
| Date Mfgr Received | 2018-06-06 |
| Date Added to Maude | 2018-06-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | MR. PETER NIZIOLEK |
| Manufacturer Street | 75 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SANI-SCOPE DISP ANOSCOPE |
| Generic Name | SANI-SCOPE DISP ANOSCOPE |
| Product Code | HIB |
| Date Received | 2018-06-27 |
| Model Number | 82420 |
| Catalog Number | 82420 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DR TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-27 |