MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-10-05 for PRATT RECTAL PROBE 10 IN SHAFT 7-3/4 IN 28-108 manufactured by .
[15409100]
The customer reports via medwatch submitted to miltex that a pt was undergoing surgical procedure for anal fistula. During the procedure a rectal probe was used and the distal end of probe broke off into the pt. The surgeon was unable to retrieve the foreign body and it remains in the pt. The foreign body was confirmed by x-ray. Post operative x-ray the same day. The user reports the approximate age of device is 6 years. No serious harm to pt per customer.
Patient Sequence No: 1, Text Type: D, B5
[15729111]
The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported info. Customer will not release device for investigation. Photographs requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2010-00010 |
| MDR Report Key | 1880941 |
| Report Source | 06 |
| Date Received | 2010-10-05 |
| Date of Report | 2010-10-05 |
| Date of Event | 2010-09-15 |
| Date Mfgr Received | 2010-09-28 |
| Date Added to Maude | 2010-12-09 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRATT RECTAL PROBE 10 IN SHAFT 7-3/4 IN |
| Generic Name | M17 - RECTAL |
| Product Code | EXX |
| Date Received | 2010-10-05 |
| Catalog Number | 28-108 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-05 |