MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2014-03-24 for ALL-FLEX ARCHING SPRING DIAPHRAGM (SILICONE UNK manufactured by Johnson & Johnson Medical Brazil.
[16450482]
This spontaneous report received from a pt, via (b)(6), the united states (local id number (b)(6)). The pt's height, weight, and medical history were unk. The pt was prescribed an all-flex arcing spring diaphragm silicone on an unspecified date. Concomitant medication(s) were not reported. On an unk date, the pt experienced difficultly in removing her diaphragm. The pt sent an email to the medical info group in (b)(6) stating that she has "difficulty removing her ortho diaphragm" and that her "fingers are not long enough". She inquired about identifying a "tool available to hook onto the rim so that she could pull it out". She indicated that she had tried to find such a tool on the web to purchase, but was unsuccessful. The pt outcome was unk for experiencing difficulty in removing the diaphragm. This report was associated with a product quality complaint (pqc) number (pqc number (b)(4)). This report was non reportable (malfunction).
Patient Sequence No: 1, Text Type: D, B5
[16692598]
The lot number was not provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2242843-2014-00186 |
| MDR Report Key | 3770339 |
| Report Source | 04,06 |
| Date Received | 2014-03-24 |
| Date of Report | 2014-03-17 |
| Date Facility Aware | 2014-03-17 |
| Report Date | 2014-03-17 |
| Date Reported to FDA | 2014-03-20 |
| Date Reported to Mfgr | 2014-03-14 |
| Date Mfgr Received | 2014-03-14 |
| Date Added to Maude | 2014-05-16 |
| 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 | 0 |
| Manufacturer Street | 1125 TRENTON-HARBOURTON RD |
| Manufacturer City | TITUSVILLE NJ 08560 |
| Manufacturer Country | US |
| Manufacturer Postal | 08560 |
| Manufacturer Phone | 2153257722 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALL-FLEX ARCHING SPRING DIAPHRAGM (SILICONE |
| Product Code | HDW |
| Date Received | 2014-03-24 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON MEDICAL BRAZIL |
| Manufacturer Address | SAO JOSE DOS CAMPOS BR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-24 |