MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-10-17 for OLYMPUS-KEYMED KAD-1 SMALL DILATOR (20-27FR) 7094124 (DILATOR PART NO) manufactured by Keymed (medical & Industrial Equipment) Ltd..
[112262]
A verbal report was received from the medical physics engineer on 1997, indicating that the small dilator (20-27fr) from a keymed manufactured kad-1 kit had split during use. He asked if the other two dilators from the kit could be returned for examination. No indication of any injury to a patient was given. The other two dilators were examined and tested by keymed and returned to the hospital as they were deemed to be fit for further use. On 9-1-1997, keymed received a letter from the uk medical devices agency (mda), with a copy of an incident report from the hospital, stating that the patient suffered a perforated esophagus as a result of the incident. On 10-3-1997, keymed received a further communication from the mda, to report that the patient had since died. Keymed has asked the mda to assist in making the suject dilator available for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-1997-00002 |
| MDR Report Key | 126915 |
| Report Source | 06 |
| Date Received | 1997-10-17 |
| Date of Report | 1997-10-09 |
| Date of Event | 1997-08-01 |
| Date Mfgr Received | 1997-09-01 |
| Device Manufacturer Date | 1992-05-01 |
| Date Added to Maude | 1997-10-21 |
| 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 | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS-KEYMED |
| Generic Name | ESOPHAGEAL DILATOR |
| Product Code | EZM |
| Date Received | 1997-10-17 |
| Model Number | KAD-1 SMALL DILATOR (20-27FR) |
| Catalog Number | 7094124 (DILATOR PART NO) |
| Lot Number | * |
| ID Number | 7094205 (KAD-1 KIT PART NO) |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 124204 |
| Manufacturer | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD. |
| Manufacturer Address | STOCK RD, SOUTHEND-ON-SEA ESSEX UK SS2 5QH |
| Baseline Brand Name | OLYMPUS-KEYMED |
| Baseline Generic Name | ESOPHAGEAL DILATOR |
| Baseline Model No | KAD-1 SMALL DIL |
| Baseline Catalog No | 7094124 (DILATOR PART NO) |
| Baseline ID | 7094205 (KAD-1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1997-10-17 |