MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-05-22 for MEDGYN LAMINARIA UNK manufactured by Medgyn Products, Inc..
[20831399]
We have no info on who used the product, which size of laminaria, or which lot number of laminaria was used on the pt. We were not informed who filed the report, who the user physician was, or in which city or country the incident occurred. The product did not come back to us, and there is no follow up investigation which we can carry out. We have never had such bradycardia and blood pressure effect reported to us in the past. This incident is the first report of this type of heart rate and blood pressure effect we have come across.
Patient Sequence No: 1, Text Type: N, H10
[20842346]
Medgyn products, inc. Did not receive a report about the incident from the end user, the only info we have is from the report fda sent to us. A pt was given peracervical lidocaine 1% 10 ml, and then 7 laminaria were inserted. Pt had abdominal cramping and felt light headed, dizzy, and thirsty. Five minutes after insertion, blood pressure and heart rate dropped from 107/64; 82 to 94/59; 67. Pt was monitored, but there was no improvement. Pt was given atropine 1 mg iv and percocet 5/235 mg x 1. Blood pressure and heart rate improved with recurrence of bradycardia and hypotension. Pt was admitted to a hospital for observation and had her procedure performed the next day as scheduled. We found out from fda letter. Identity of initial reporter not revealed to us by fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1450908-2009-00001 |
| MDR Report Key | 1395953 |
| Report Source | 00 |
| Date Received | 2009-05-22 |
| Date of Report | 2009-05-22 |
| Date of Event | 2009-04-21 |
| Date Mfgr Received | 2009-05-14 |
| Date Added to Maude | 2009-06-02 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | RAMESH VYAS |
| Manufacturer Street | 328 N. EISENHOWER LN. |
| Manufacturer City | LOMBARD IL 60148 |
| Manufacturer Country | US |
| Manufacturer Postal | 60148 |
| Manufacturer Phone | 6306274105 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDGYN LAMINARIA |
| Generic Name | HDY HYGROSCOPIC LAMINARIA CERVICAL DILATOR |
| Product Code | HDY |
| Date Received | 2009-05-22 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDGYN PRODUCTS, INC. |
| Manufacturer Address | LOMBARD IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2009-05-22 |