MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-03-05 for MED. SPEC.W/INTREGATED SHEATH 58001S manufactured by Welch Allyn, Inc.
[101561417]
A (b)(6) week pregnant patient presented to the ob unit for observation with complaints of vaginal discharge and discomfort. A pelvic exam was started using a wa kleenspec vaginal speculum with a sheath. A wet and std swab were obtained. , both were negative. At 22:05 the patient presented with swelling of the throat, increased heart rate and elevated bp, the baby's tracing was unremarkable throughout the episode. A rapid response was called. Epinephrine and steroids were administered iv and the patient transferred to the er for observation. The patient did maintain her airway. She was discharged from the er after several hours and is doing well with no further issues. The patient has a known allergy to latex, iodine and plastic tape. The observation unit uses wa kleenspec vaginal speculums, the ob clinic where the patient receives routine ob care does not use disposable speculums. It is unclear if the patient has ever been exposed to the wa speculum in any previous exams. A review of all product components and packaging determined that the vag spec product and packaging does not contain latex. This mdr is filed due to serious injury. There was no malfunction of the device.
Patient Sequence No: 1, Text Type: N, H10
[101561418]
Welch allyn received a report from a welch allyn customer stating that they used a welch allyn vaginal speculum on a patient with a known latex allergy and she experienced an anaphylaxis reaction. This report was filed in our complaint handling system as complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1316463-2018-00003 |
| MDR Report Key | 7314347 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-05 |
| Date of Report | 2018-02-05 |
| Date of Event | 2018-02-05 |
| Date Mfgr Received | 2018-02-05 |
| Date Added to Maude | 2018-03-05 |
| 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 | DR EDWARD O'NEIL |
| Manufacturer Street | 4341 STATE STREET RD P.O. BOX 220 |
| Manufacturer City | SKANEATELES FALLS 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal | 131530220 |
| Manufacturer Phone | 3155544055 |
| Manufacturer G1 | WELCH ALLYN, INC |
| Manufacturer Street | 4341 STATE STREET RD P.O. BOX 220 |
| Manufacturer City | SKANEATELES FALLY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 131530220 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MED. SPEC.W/INTREGATED SHEATH |
| Generic Name | MED. SPEC.W/INTREGATED SHEATH |
| Product Code | HIB |
| Date Received | 2018-03-05 |
| Model Number | 58001S |
| Catalog Number | 58001S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN, INC |
| Manufacturer Address | 4341 STATE STREET RD P.O. BOX 220 SKANEATELES FALLS 131530220 US 131530220 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-05 |